COMMISSION STAFF WORKING DOCUMENT EVALUATION of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the review of the Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment
Date: 2023-12-07
Institutions: Directorate-General for Environment, European Commission
Subjects: dangerous substance, electronic equipment, electronic waste, hazardous waste, lighting equipment, market supervision, marketing standard, regulatory policy, waste recycling

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.12.2023  SWD(2023) 760 final  COMMISSION STAFF WORKING DOCUMENT EVALUATION                               of                                 Directive 2011/65/EU                                on the restriction of the use of certain hazardous substances in electrical and electronic equipment Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the review of the Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment {COM(2023) 760 final}  
 
 
Table of contents 

1 

INTRODUCTION ................................................................................................................................ 6 

1.1 

1.2 

1.3 

1.4 

Purpose of the evaluation ..................................................................................... 6 

Scope of the evaluation ........................................................................................ 7 

Evaluation criteria covered .................................................................................. 7 

Evaluation process ............................................................................................... 8 

1.4.1 

Desk research................................................................................................ 8 

1.4.2 

Consultations ................................................................................................ 8 

1.4.3 

Quantitative analysis .................................................................................... 9 

1.5  Methodological limitations and robustness of findings ....................................... 9 

1.5.1 

Stakeholder consultation .............................................................................. 9 

1.5.2 

Data limitations .......................................................................................... 10 

2  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? ..................................... 11 

2.1  Objective of the intervention ............................................................................. 11 

2.2  Description of the intervention .......................................................................... 11 

2.3 

Point(s) of comparison ....................................................................................... 12 

2.3.1 

Scope .......................................................................................................... 13 

2.3.2 

Substance restrictions ................................................................................. 13 

2.3.3 

Derogations and time-limited exemptions.................................................. 14 

2.3.4 

Declarations of conformity and CE marking .............................................. 16 

3 

HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? ....................... 17 

3.1 

3.2 

3.3 

Transposition of the RoHS Directive and delegated acts .................................. 17 

Implementation and enforcement ...................................................................... 17 

Interactions with other EU policies and legislation ........................................... 19 

4 

EVALUATION FINDINGS ............................................................................................................... 21 

4.1 

To what extent was the RoHS Directive successful and why? .......................... 21 

4.1.1 
The  RoHS  Directive  achieved  its  primary  objective  of  restricting  and 
thereby reducing the use of certain hazardous substances in EEE ............................ 22 

4.1.2 
Achieving a reduction in hazardous substances is expected to have positive 
effects on human health and the environment. .......................................................... 25 

4.1.3 
The RoHS Directive has contributed to the environmentally sound recovery 
and disposal of waste EEE ........................................................................................ 28 

1 

 
 
4.1.4 
By  introducing  harmonised  restrictions,  the  RoHS  Directive  has  created  a 
level  playing  field  for  all  manufacturers,  thus  effectively  contributing  to  the 
functioning of the internal market ............................................................................. 29 

4.1.5 

Regulatory benefits counterbalance the regulatory costs ........................... 31 

4.1.6 

The exemption process is not sufficiently transparent and efficient .......... 37 

The  substance  restriction  process  is  not  sufficiently  transparent  and 

4.1.7 
efficient 40 

4.1.8 

Lack of clarity and adaptation provisions to reflect latest developments .. 41 

4.1.9 
Lack of coherence (consistency) with other related pieces of legislation and 
policy goals ............................................................................................................... 42 

4.2  How did the RoHS Directive make a difference?.............................................. 45 

4.2.1 

The RoHS Directive has a global impact ................................................... 46 

4.3 

Is the RoHS Directive still relevant? ................................................................. 47 

4.3.1 

Identification of needs ................................................................................ 48 

Correspondence between the Directive’s original objectives and the current 
4.3.2 
and future environment, health and internal market needs ....................................... 49 

4.3.3 

Aspects that may impact the RoHS Directive’s relevance ......................... 49 

5 

CONCLUSIONS AND LESSONS LEARNED ................................................................................. 50 

5.1 

Lessons learned .................................................................................................. 52 

6 

7 

8 

9 

ANNEX I: PROCEDURAL INFORMATION ................................................................................... 53 

ANNEX II. METHODOLOGY AND ANALYTICAL METHODS USED ...................................... 54 

ANNEX  III.  EVALUATION  MATRIX  AND  DETAILS  ON  ANSWERS  TO  THE 
EVALUATION QUESTIONS (BY CRITERION) ............................................................................ 56 

ANNEX IV. OVERVIEW OF BENEFITS AND COSTS ESTIMATES ........................................... 71 

10  ANNEX V. STAKEHOLDER CONSULTATION – SYNOPSIS REPORT ..................................... 76 

1. 

Introduction ......................................................................................................... 76 

2.  The consultation strategy .................................................................................... 76 

3.  Online public consultation .................................................................................. 76 

3.1 

3.2 

3.3 

3.4 

Participants ................................................................................................ 76 

Outcome of the questionnaire for the non-experts ..................................... 78 

Outcome of the questionnaire for experts .................................................. 79 

Additional input and position papers ......................................................... 80 

4.  Questionnaire to Member States ........................................................................ 80 

4.1 Participants ......................................................................................................... 80 

4.2 Outcome .............................................................................................................. 81 

5.  Focus groups ........................................................................................................ 82 

1 Participants ............................................................................................................ 82 

2 

 
2 Outcome ................................................................................................................. 82 

6.  Targeted interviews ............................................................................................. 83 

1 Participants ............................................................................................................ 83 

2 Outcome ................................................................................................................. 84 

7.  Workshop ............................................................................................................. 84 

3 

 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

AdCo 

BBP 

Cd 

CE 

Administrative  cooperation  groups  – 
surveillance  

informal  groups  cooperating  on  market 

Benzyl Butyl phthalate 

Cadmium 

European conformity mark signifying compliance with the European requirements 

CEAP 

Circular economy action plan – Communication COM/2020/98  

Cr-(VI) 

Hexavalent chromium  

DBP 

Dibutyl phthalate 

Deca-BDE 

Decabromodiphenyl ether 

DEHP 

DIBP 

EEA 

EEE 

FTE 

Hg 

LED 

Bis(2-ethylhexyl) phthalate 

Diisobutyl phthalate 

European Economic Area 

Electrical and electronic equipment 

Full-time equivalent 

Mercury 

Light-emitting diode 

Member States 

Member States as addressed under the RoHS Directive (‘Text with EEA relevance’): 27 
Member  States  of  the  European  Union  plus  three  States  of  the  European  Economic 
Area (Norway, Iceland, Liechtenstein) 

NGO 

NLF 

OPC 

Pb 

PBB 

PBDE 

POPs 

Non-governmental organisation 

New Legislative Framework 

Online public consultation 

Lead 

Polybrominated biphenyls 

Polybrominated diphenyl ethers 

Regulation  (EC)  No 850/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April 2004 on persistent organic pollutants (OJ L 158, 30.4.2004, p. 7) 

4 

 
 
R&D 

RAC 

REACH 

RFID 

RoHS 

SEAC 

Research & development 

Committee  for  Risk  Assessment,  set  up  under  Article 76(1)(c)  of  Regulation  (EC) 
No 1907/2006 

Regulation  (EC)  No 1907/2006  of  the  European  Parliament  and  of  the  Council  of 
18 December  2006  concerning  the  Registration,  Evaluation,  Authorisation  and 
Restriction  of  Chemicals  (REACH),  establishing  a  European  Chemicals  Agency, 
amending  Directive  1999/45/EC  and  repealing  Council  Regulation  (EEC)  No 793/93 
and  Commission  Regulation  (EC)  No 1488/94  as  well  as  Council  Directive 
76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1) 

Radio frequency identification (tags) 

Directive  2011/65/EC  on  the  restriction  of  the  use  of  certain  hazardous  substances  in 
electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88) 

Committee  for  Socio-economic  Analysis, set  up  under  Article 76(1)(d)  of  Regulation 
(EC) No 1907/2006 

SME  

Small and medium-sized enterprises 

Waste EEE 

Waste electrical and electronic equipment (or WEEE) 

WEEE Directive 

Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on 
waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38) / 

XRF 

X-ray fluorescence 

5 

 
1 

INTRODUCTION 

1.1  Purpose of the evaluation 

Under  Article 24(2)  of  Directive 2011/65/EU  of  the  European  Parliament  and  of  the 
Council  of  8 June 2011  on  the  restriction  of  the  use  of  certain  hazardous  substances  in 
electrical and electronic equipment (recast)1 (referred to below as ‘the RoHS Directive’ 
or ‘the Directive’), the Commission must review the Directive no later than 22 July 20212 
and present a report to the European Parliament and the Council. This document presents 
an evaluation of the Directive in line with the Commission’s policy on better regulation. 
The  results  of  this  evaluation  may  feed  into  any  subsequent  proposal  to  revise  the 
Directive3, and any non-legislative follow-up action. 

The  context  is  set  by  the  European  Green  Deal4  and  the  2020  circular  economy  action 
plan5  (CEAP).  The  Green  Deal  identifies  electronics  as  a  ‘resource-intensive’  sector, 
together with textiles, construction materials and plastics, while, in the CEAP, electronics 
are  part  of  one  of  the  seven  key  product  value  chains  selected  for  action  to  increase 
circularity. The electrical and electronic equipment (EEE) sector is evolving fast, and its 
products  are  becoming  more  diverse  and  complex.  EEE  production  and  sales  are 
increasing  and at  the  same time the  products’ use phases are becoming  shorter. This  is 
generating  an  increasing  volume  of  waste  electrical  and  electronic  equipment  (WEEE), 
and  creating  an  environmental  challenge:  how  to  disassemble  and  recycle  complex 
products?  The  presence  of  certain  hazardous  substances  in  EEE  prevents  today’s 
products  from  being  recycled  tomorrow  and  hampers  circular  economy  ambitions. 
Furthermore, it poses risks to the environment and human health, especially when WEEE 
does not enter the designated disposal route, which is still too often the case. In addition, 
the  current  CEAP  includes  an  action  on  ‘[reviewing]  EU  rules  on  restrictions  of 
hazardous substances in electrical and electronic equipment and [providing] guidance to 
improve  coherence  [i.e.  consistency]  with  relevant  legislation,  including  REACH  and 
Ecodesign’.  Other  relevant  initiatives  that  set  policy  priorities  have  been  taken  into 
account,  such  as  the  chemicals  strategy  for  sustainability6  or  the  sustainable  product 
policy7.  Furthermore,  in  December  2022,  an  evaluation  of  the  WEEE  Directive8  was 
launched (see details in chapter 2.2). 

1   Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use 

of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88). 

2   Whilst preparations for the general review started before 22 July 2021, the timetable was amended, to align it with 

other actions relating to sustainable products and chemicals listed in the European Green Deal. 

3   Report  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European  Economic  and  Social 
Committee and the Committee of the Regions on the review of the Directive on the restriction of the use of certain 
hazardous substances in electrical and electronic equipment, COM(2023)760. 

4   COM(2019) 640 final. 

5   COM(2020) 98 final. 

See also COM(2022) 142 final: proposal for a regulation on ecodesign for sustainable products. 

6   COM(2020) 667 final. 
7  
8   Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and 
electronic  equipment  (WEEE),  OJ L 37,  13.2.2003,  p. 24,  repealed  by  Directive  2012/19/EU  of  the  European 

6 

 
 
 
 
1.2  Scope of the evaluation 

its 
This  evaluation  covers  Directive  2011/65/EU 
implementation in all EU Member States10, from the transposition deadline of 2 January 
201311 until December 2022. Accordingly, this report analyses both issues relating to the 
legislation itself, and to its transposition and application in the Member States. 

including  amendments9  and 

1.3  Evaluation criteria covered 

In  line  with  the  Commission’s  Better  Regulation  Guidelines12,  this  report  assesses  the 
Directive according to the following five evaluation criteria. 

✓  Effectiveness.  How  well  has  EU  legislation  achieved  its  objectives  of  (a)  reducing 
hazardous  substances  in  EEE  in  the  EU  and  thus  protecting  human  health  and  the 
environment  at  different  stages  of  the  value  chain  (e.g.  production),  and  (b) 
contributing to the harmonisation and functioning of the internal market? 

✓  Efficiency. Have the obligations arising from the RoHS Directive been implemented 
in  an  economically  efficient  way  and  is  there  potential  for  further  synergies  to 
improve  outcomes  while  minimising  costs  and  administrative  burden,  including  the 
impact on small and medium enterprises (SMEs)? 

✓  Relevance. Are the issues addressed by the RoHS Directive still  relevant to current 
needs  (e.g.  new  hazardous  substances)  and  does  the  Directive  help  with  issues 
addressed by wider EU policies on chemicals, circular economy, raw materials etc.? 
Is  the  Directive  in  line  with  the  policy  priorities  and  related  initiatives  adopted 
subsequently, as  set  out  in  the European Green  Deal,  the CEAP or,  for  example,  in 
the chemicals strategy for sustainability13? 

✓  Coherence.  How  coherent  (consistent)  and  connected  is  the  RoHS  Directive  with 
EU-wide policy objectives on circular economy? What inconsistencies and overlaps 
might there be between the Directive and related legislation on hazardous substance 
restrictions, electronics and waste, such as Regulation (EC) No 1907/2006 (‘REACH 
and 
Regulation’)14,  Regulation 
Directive 2009/125/EC (Ecodesign)16 measures? 

(‘POPs  Regulation’)15 

(EC)  No 850/2004 

Parliament  and  of  the  Council  of  4 July 2012  on  waste  electrical  and  electronic  equipment  (WEEE)  (OJ L 197, 
24.7.2012, p. 38). 

9   The  latest  consolidated  version  of  Directive  2011/65/EU  encompassing  80  amendments  is  available  at 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20230301 

10   NB:  The  United  Kingdom  was  still  a  Member  State  of  the  European  Union  at  the  time  of  the  stakeholder 

consultations related to this evaluation of the RoHS Directive. 
In line with Article 25 of Directive 2011/65/EU. 

11  
12   SWD(2021) 305 final 

13   COM(2020) 667 final. 
14   Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning 
the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH),  establishing  a  European 
Chemicals Agency, amending Directive 1999/45/EC (OJ L 396, 30.12.2006, p. 1). 

15   Regulation  (EC)  No 850/2004  of  the  European  Parliament  and  of  the  Council  of  29 April  2004  on  persistent 

organic pollutants (POPs) (OJ L 158, 30.4.2004, p. 7). 

16   Directive  2009/125/EC  of  the  European  Parliament  and  of  the  Council  of  21 October  2009  establishing  a 
framework  for  the  setting  of  ecodesign  requirements  for  energy-related  products  (Text  with  EEA  relevance) 
(OJ L 285, 31.10.2009, p. 10). 

7 

 
 
✓  EU  added  value.  What  is  the  added  value  of  the  Directive  compared  to  what 
Member States could have reached acting alone at national, regional and international 
level? 

1.4  Evaluation process 

The Commission’s work on this evaluation was supported by an external contractor. The 
external  study  (referred  to  below  as  ‘the  evaluation  study’)  was  finalised  in  March 
202117. Most of the data presented here were taken from this evaluation study. 

In  March  2021,  another  study  was  launched  to  propose  options  to  improve  the 
deficiencies identified in the evaluation study and to assess their possible impacts. As it 
became apparent during the work that no full impact assessment is necessary, the work 
shifted to filling data gaps for the evaluation. This second support study (‘second support 
study’)18 was published in May 2023. In order to  have more complete results, this  staff 
working  document has been supplemented and therefore published later than originally 
planned. 

The  main  steps  undertaken,  and  sources  of  information  used  for  this  evaluation  are 
presented  in  the  following  sub-sections.  More  information  on  the  methodology  and 
process  followed for this  evaluation  (including on the consultation  of stakeholders) can 
be found in Annex V. 

1.4.1  Desk research 

Relevant data and literature were identified, screened and reviewed, including: legal acts 
and documents relating to implementation of the Directive; exemption evaluation reports 
and  reports  on  hazardous  substance  restrictions19;  EEE  statistics  from  Eurostat20;  and 
relevant impact assessment studies. 

1.4.2  Consultations 
A number of stakeholder consultation activities took place. 

−  The  Commission  published  an  evaluation  roadmap  for  the  RoHS  Directive  in 
2018,  which  was  open  for  public  feedback  from  14 September  2018  to 
12 October 2018 and received 20 responses21. 

−  An online public consultation (OPC) organised by the Commission was open for 
12 weeks, 
total, 
from  13 September 2019  until  6 December 201922. 
163 responses  were  collected.  125 responses  (77%)  were  submitted  directly  via 
the ‘Have Your Say’ portal. The other 38 responses (23%) were submitted via a 

In 

17   European Commission, Directorate-General for Environment, Support for the evaluation of Directive 2011/65/EU 
on the restriction of the use of certain hazardous substances in electrical and electronic equipment: final report, 
Publications Office, 2021, https://data.europa.eu/doi/10.2779/89335. 

18   Study to support the assessment of impacts associated with the general review of Directive 2011/65/EU (RoHS 
https://op.europa.eu/en/publication-detail/-/publication/b9188764-f465-11ed-a05c-

- 

Directive) 
01aa75ed71a1/language-en/format-PDF/source-286516984  

19   https://ec.europa.eu/environment/topics/waste-and-recycling/rohs-directive_en#ecl-inpage-623 
20   https://ec.europa.eu/eurostat/web/waste/overview 
21 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1891-Hazardous-substances-in-electrical-
electronic-equipment-evaluation-of-restrictions_en 
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1891-Restriction-of-hazardous-substances-evaluation 

22 

8 

 
 
representative of the Enterprise Europe Network from the United Kingdom (UK) 
who uploaded a file with 38 (23%) company responses to the general part of the 
survey, as part of an answer to the OPC. Most replies came from respondents in 
the  UK  (51 responses)  and  Belgium  (32 responses),  followed  by  Germany  (25) 
and Japan (16). Almost half of the replies, 77, were from respondents outside the 
EU (Japan, UK, Switzerland, others)23.  

− 

In  parallel  to  the  OPC,  an  in-depth  survey  (questionnaire)  was  shared  with 
Member State authorities involved in implementing the RoHS Directive. A total 
of  20 responses  were  received,  of  which  one  was  not  counted  in.  Of  the 
respondents,  13 completed  the  questionnaire  fully,  while  6 responded  partially. 
Responses were provided by authorities from 15 Member States and Norway. 

−  Between  October 2019  and  March 2020,  three  focus  group  meetings  were 
organised  covering  the  following  topics:  (i)  for  Member  States  authorities 
regarding assessment of implementation and enforcement of the Directive, (ii) for 
NGOs regarding effectiveness and efficiency as well as environmental and health 
aspects,  (iii)  for  business  associations  regarding  effectiveness  and  efficiency  as 
well as costs and benefits aspects and (iv) external and internal coherence. 

−  15 in-depth  interviews with  targeted stakeholders (e.g. manufacturer, distributor, 
NGOs) were held, partly as follow-up to stakeholder input provided via the OPC. 

−  A virtual workshop was held in March 2020 to present the preliminary findings of 
the  study  and  provide  stakeholders  with  another  opportunity  to  give  input. 
Around  125 individuals  joined  the  webinar.  It  brought  together  representatives 
from  12 Member  States  and  53 representatives  from  NGOs  and  industry.  The 
organisations that had been interviewed and some people from the focus groups 
took part in the workshop. Moreover, prior to the workshop, 25 organisations sent 
contributions. 

1.4.3  Quantitative analysis 

To assess the effectiveness of the RoHS Directive quantitatively, an evaluation ‘baseline 
scenario’  (in  which  the  Directive  was  assumed  not  to  exist)  was  established  in  the 
evaluation  study.  The  analysis  made  it  possible  to  estimate  the  amount  of  harmful 
substances which were avoided to be placed on the market.  

1.5  Methodological limitations and robustness of findings 

1.5.1  Stakeholder consultation 

•  The contribution from civil society and non-governmental organisations (NGOs) was 
limited, including their participation in the dedicated focus group. This is due mainly 
to  the  lack  of  staff  working  on  the  RoHS  Directive  in  those  categories  of 
stakeholders. 

23   Through, at the time the OPC was open, the United Kingdom was still an EU Member State. 

9 

 
 
• 

In the OPC, the vast majority of respondents were ‘business organisations’, which is 
understandable as the Directive concerns internal market harmonisation. 

•  To  mitigate  the  limited participation  by  NGOs,  supplementary  methods  were  used. 
For  instance,  on  12 December  2019,  a  focus  group  with  NGOs  discussed  the 
Directive’s  effectiveness  and  efficiency  with  regards  to  environmental  and  health 
aspects. 

1.5.2  Data limitations 

Despite  considerable  efforts  made  during  the  evaluation  process,  data  collection  was 
inadequate in certain crucial respects, outlined below. 

•  Data  is  lacking  on  the  concentration  of  hazardous  substances  in  EEE  waste  per 
category  of  product;  sufficient  data  was  not  available  on  the  weight  of  the 
‘homogeneous materials’ in the EEE for which the maximum concentration values are 
regulated. Therefore, the model developed to determine the quantitative impact of the 
RoHS  Directive  on  the  quantities  of  hazardous  substances  in  EEE  is  limited  to 
mercury, lead and cadmium24. 

•  Availability of data is limited for the period before and around implementation of the 
RoHS  Directive,  and  for  more  recent  years.  The  model  developed  to  quantify  the 
impacts of the RoHS Directive on the quantities of hazardous substances focused on 
the baseline and the period when the first RoHS Directive (2002/95/EC) was in place. 

•  It was not possible to collect precise information from the literature review or through 
interviews.  Some  of  the  stakeholders  interviewed  and  focus  group  participants 
indicated that this could be due to the lack of a reliable monitoring framework before 
the first  RoHS  Directive (2002/95/EC) and the  possibility  that  sufficient  amounts of 
RoHS-compliant  EEE  had  not  yet  reached  the  end  of  their  life  cycle.  Therefore, 
estimations  and  assumptions  had  to  be  made.  For  example,  the  concentration  of 
hazardous substances in EEE components without an exemption were  assumed to be 
0%  by  weight,  even  though  the  maximum  allowed  threshold  value  would  be  higher 
under Annex II to the RoHS Directive. 

•  It  is  almost  impossible  to  relate  a  reduction  in  hazardous  substances  in  EEE  to  one 
specific  piece  of  legislation  or  initiative  in  a  reliable  manner.  Over  the  years,  other 
legislative  developments  and  instruments  have  also  had  an  impact  on  the  use  of 
RoHS-restricted  substances.  This  includes  the  REACH  Regulation  at  EU  level,  but 
also national initiatives. 

•  As regards the data on costs and benefits: 

-  companies were not able to provide precise data on the percentage of turnover 
spent  on  RoHS  compliance,  either  in  terms  of  their  initial  investment  cost  or 
operating expenditure; 

- 

some companies found it easier to provide full-time equivalent (FTE) estimates, 
the  highest  estimates  having  been  provided  by  businesses  representing  EEE 
categories  3  (‘IT  and  telecommunications  equipment)’,  8  (‘medical  devices’) 

24 Deca-BDE was considered, but insufficient data prevented further analysis and conclusions. 

10 

 
 
and 9 (‘monitoring and control instruments including industrial monitoring and 
control instruments)25; 

- 

there  was  sufficient  data  for  an  estimate  of  costs,  but  not  for  an  overall 
assessment of the costs; 

-  due  to  the  lack  of  precise  data  on  the  reduction  in  the  amount  of  hazardous 
substances  used  in  EEE,  it  was  largely  impossible  to  quantify  the  benefits  in 
terms of reduction in hazardous substances on the market (see above). 

The  above  data  limitations  have  restricted  the  analysis  substantially.  Triangulation  of 
sources  was  critical  in  making  the  findings  more  robust.  Where  primary  data  was  not 
available, the evaluation relied on literature and experts’ opinions. The report needs to be 
read with these caveats in mind; it cannot provide a precise assessment, but the findings 
reflect the order of magnitude of the impacts. 

2  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? 

2.1  Objective of the intervention 

The  key  objectives  of  the  RoHS  Directive  are:  to  reduce  the  amount  of  hazardous 
substances  in  EEE  to  protect  human  health  and  the  environment;  and  to  facilitate  the 
environmentally sound recovery and disposal of waste EEE. The Directive also aims to 
ensure the  functioning  of the internal  market26 through harmonisation  of  Member State 
legislation27.  Moreover,  besides  the  key  provisions  on  substance  restrictions,  the  RoHS 
Directive also includes a number of provisions aimed at enabling the reuse and repair of 
EEE  containing  restricted  substances,  to  help  promote  resource  efficiency  and  circular 
economy objectives. 

2.2  Description of the intervention 

EEE is a highly diverse product group characterised by fast innovation cycles, which lead 
to  continuous  changes  in  equipment  features,  performance  and  materials  used.  EEE 
contains  various  substances  that  may  present  hazardous  characteristics  and  thus  pose  a 
risk to the environment and to human health during the production and use of EEE, and 
the  collection,  treatment  and  disposal  of  waste  EEE.  Several  Member  States  have 
addressed these problems by introducing national requirements. 

In  response  to  the  challenges  outlined  above,  in  2000,  the  European  Commission 
proposed  EU  legislation  to  address  human  health  and  environmental  concerns  and  to 
harmonise  EEE-related  legislation  across  Member  States28.  As  a  result,  the  European 
Parliament and the Council adopted Directive 2002/95/EC on the restriction of the use of 

25 Annex I to the RoHS Directive lays down the 11 categories of EEE covered by this Directive. 
26 Recital 2 of the RoHS Directive reads: ‘The disparities between the laws or administrative measures adopted by the 
Member States regarding the restriction of the use of hazardous substances in electrical and electronic equipment 
(EEE) could create barriers to trade and distort competition in the Union and may thereby have a direct impact on 
the establishment and functioning of the internal market. It therefore appears necessary to lay down rules in this 
field and to contribute to the protection of human health and the environmentally sound recovery and disposal of 
waste EEE’. 

27 The RoHS Directive is also relevant for the European Economic Area (EEA). 
28 COM(2000) 347, 2000/0159 (COD) (OJ C 365E, 19.12.2000, p. 195). 

11 

 
 
certain  hazardous  substances  in  EEE  (the  ‘RoHS 1  Directive’)29  and  Directive 
2002/96/EC  on  waste  electrical  and  electronic  equipment  (the  ‘WEEE  Directive’).  The 
latter  sets  rules  for  the  collection,  treatment,  recycling  and  disposal  of  WEEE,  to 
contribute  to  more  sustainable  production  and  consumption.  However,  even  if  WEEE 
were  collected  separately  and  sent  for  recycling,  the  hazardous  substances  it  contained 
would  likely  pose  a  risk  to  health  and  the  environment.  Restricting  the  use  of  these 
hazardous substances is likely to increase the possibilities for WEEE recycling, to make 
recycling  more  profitable  and  to  decrease  the  negative  health  impact  on  workers  in 
recycling plants. 

2.3  Point(s) of comparison 

to 

revised 

leading 

in  2011, 

the  adoption  of 
The  RoHS 1 Directive  was 
Directive 2011/65/EU.  The  aims  of  the  revision/recast  process  were:  (i)  to  improve  the 
Directive  in  terms  of  implementation,  enforcement  and  coherence;  (ii)  to  review  the 
measures  provided  for  in  the  Directive,  in  particular  with  a  view  to  including  two 
additional categories30 of equipment in the scope (categories 8 and 9: medical devices and 
monitoring and control instruments respectively); and (iii) to amend the list of restricted 
substances. The objectives of the revised Directive remained the same: to protect human 
health  and  the  environment,  to  ensure  environmentally  sound  recovery  and  disposal  of 
waste EEE, and to ensure the functioning of internal market. 

The  key  changes  from  Directive  2002/95/EC  to  Directive  2011/65/EU  are  summarised 
below. 

•  The  Directive’s  scope  was  gradually  extended  to  cover  all  EEE,  cables  and  spare 
parts31.  The  initial  Directive  specifically  called  for  the  scope  to  be  reviewed  in 
respect  of  EEE.  The  scope  was  then  amended  to  strengthen  the  objectives  of  the 
Directive, in particular to promote a circular economy in the EU. 

•  Provisions  were  added  on  regular  reviewing  of  the  list  of  restricted  hazardous 
substances  and  amending  them  by  delegated  acts,  to  ensure  consistency  and 
coherence between different pieces of EU legislation. 

•  The exemption mechanism was improved, with clearer and more transparent rules on 
granting,  renewing  or  deleting  exemptions  and  on  exemption  applications  and 
required documentation. 

•  Provisions  were  added  to  improve  consistency  with  other  EU  legislation  and 
especially with the New Legislative Framework32 (e.g. CE marking and declaration 
of  conformity)  and  REACH  (for  example,  exemptions  under  Article 5(1)(a)  and 

29 Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the 

use of certain hazardous substances in electrical and electronic equipment (OJ L 37, 13.2.2003, p. 19). 

30 There are 11 categories of electrical and electronic equipment listed in Annex I to the RoHS Directive. 

31  As  defined  under  Article 3(1)  and  (2)  and  not  falling  under  the  exclusions  laid  down  in  Article 4  of  Directive 

2011/65/EU. 

32  The  New  Legislative  Framework  set  harmonised  requirements  for  placing  products  on  the  EU  market  and  was 
adopted  in  2008.  Some  provisions  in  the  RoHS  Directive  are  due  to  the  NLF.  For  more  information: 
https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en. 

12 

 
 
amendments to the list of restricted substances under Article 6(1) must be consistent 
with the respective REACH provisions). 

•  At  a  later  stage,  the  number  of  restricted  substances  was  increased  from  six33  to 

ten34. 

The  RoHS  Directive  evolved  over  time  as  both  restricted  substance  coverage  and 
product scope were enlarged, based on assessments35 concluded in accordance with the 
Directive.  The  current  Directive  2011/65/EU  and  its  key  operative  provisions  are 
described below. 

2.3.1  Scope 

Since July  2019, the Directive has  had  an ‘open  scope’, meaning  that, unless explicitly 
excluded,  any  product  that  meets  the  definition  of  EEE  as  laid  down  in  Article 3(1)  of 
RoHS Directive falls within its scope. 

Article 3(1)  defines  EEE  as  equipment  which  is  dependent  on  electric  currents  or 
electromagnetic  fields  in  order  to  work  properly  and  equipment  for  the  generation, 
transfer and measurement of such currents and fields and designed for use with a voltage 
rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current. 
According  to  Article 3(2),  the  term  ‘dependent’  means  ‘with  regard  to  EEE,  needing 
electric  currents  or  electromagnetic  fields  to  fulfil  at  least  one  intended  function’.  As 
such,  even  equipment  with  a  minor  function  dependent  on  electric  currents  or 
electromagnetic fields is considered an EEE. 

Article 2(1) determines that the Directive applies to EEE falling within the 11 categories 
set out in Annex I to the Directive. 

Article 2(4) provides various exclusions to the scope, for example: 

▪ 

▪ 

large-scale stationary industrial tools; 

large-scale fixed installations; 

▪  means of transport for persons or goods, excluding electric two-wheel vehicles which 

are not type-approved; 

▪  non-road mobile machinery made available exclusively for professional use; and 

▪  active implantable medical devices. 

2.3.2  Substance restrictions 

The central  mechanism  of the RoHS  Directive is  the  substance restriction laid down in 
Article 4(1).  Under  this  Article,  Member  States  must  ensure  that  EEE  placed  on  the 
market, including cables and spare parts, does not contain hazardous substances (or their 
compounds)  in  concentrations  above  a  specified  limit  value  (by  weight)  tolerated  in 

33  Lead,  mercury,  cadmium,  hexavalent  chromium,  polybrominated  biphenyls  and  polybrominated  diphenyl  ethers 

were restricted under Directive 2002/95/EC. 

34 The restriction of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and 
diisobutyl  phthalate  (DIBP)  was 
introduced  by  Commission  Delegated  Directive  (EU)  2015/863  of 
31 March 2015  amending  Annex  II  to  Directive  2011/65/EU  of  the  European  Parliament  and of  the  Council  as 
regards the list of restricted substances, OJ L 137, 4.6.2015, p. 10. 

35  Assessments,  reports  and  studies  concerning  the  review  of  Directive’s  scope  and  list  of  restricted  substance  are 
available at https://ec.europa.eu/environment/topics/waste-and-recycling/rohs-directive_en#ecl-inpage-623. 

13 

 
 
homogeneous materials. The 10 substances currently restricted36 are listed in Annex II to 
the  RoHS  Directive,  along  with  their  maximum  tolerated  concentration  values.  The 
restrictions  cover  whole  substance  groups  like  elementary  mercury  and  all  mercury 
compounds.  This  is  in  accordance  with  the  whole  life  cycle  approach  and  is  meant  to 
contribute to the simplicity of the restrictions. 

Article 6(1) lays down a procedure for a periodic review of Annex II and  specifies that 
the  first  review  was  due  by  July  2014.  Subsequently,  Commission  Delegated  Directive 
(EU) 2015/86337 added four phthalates to Annex II. The second paragraph of Article 6(1) 
contains  criteria  for  the  review  and  amendment  of  the  list  of  restricted  substances  in 
Annex  II.  The  first  criterion  is  that  amendments  should  be  ‘coherent’  (consistent)  with 
other  legislation  related  to  chemicals,  in  particular  Regulation  (EC)  No 1907/2006 
(‘REACH  Regulation’).  The  Commission  must  also  take  special  account  of  whether  a 
substance, including items which consist of this substance and have a very small size or 
very  small  internal  or  surface  structure,  or  a  group  of  similar  substances,  could:  have 
negative impact during EEE waste management operations, give rise to uncontrolled or 
diffuse  release  into  the  environment;  lead  to  unacceptable  exposure  of  workers;  or  be 
replaced by substitutes or alternative technologies (see Article 6(1), third paragraph). At 
the end of the process, the Commission should adopt delegated acts to amend Annex II. 

2.3.3  Derogations and time-limited exemptions 

Firstly,  Articles  4(4)  and  4(5)  lay  down  several  derogations  from  the  substance 
restrictions  in  Article 4(1)  which  reflect  the  ‘repair  as  produced’  principle.  Article 4(4) 
determines  that  the  substance  restrictions  in  Annex  II  do  not  apply  to  cables  or  spare 
parts for repairing, reusing or updating functionalities or for upgrading the capacity of a 
number  of  specified  EEE  categories.  The  dates  which  are  linked  to  these  derogations 
coincide with the dates of the scope extension to the new EEE categories38. 

In addition, Article 4(5) determines that the substance restrictions do not apply to reused 
spare parts for specified types of EEE, provided that: 

▪ 

▪ 

▪ 

reuse takes place in auditable closed-loop business-to-business return systems; 

the consumer is notified of reuse of spare parts; and 

reused spare parts  are  recovered from EEE placed on the market  before  a specified 
date. 

These derogations aim to facilitate the repair and reuse of EEE and therefore contribute 
to the EU’s resource efficiency and circular economy objectives. 

Furthermore, Article 4(6) of the Directive allows time-limited and application-specific 
exemptions  for  applications  listed  in  Annexes  III  and  IV,  to  which  the  substance 
restrictions  do  not  apply.  The  industry  can  submit  applications  for  time-limited 

36 Lead (0.1%),  mercury (0.1%),  cadmium (0.01%), hexavalent chromium (0.1%),  polybrominated biphenyls (PBBs) 
(0.1%),  polybrominated  diphenyl  ethers  (PBDEs)  (0.1%),  bis(2-ethylhexyl)  phthalate  (DEHP)  (0.1%),  butyl 
benzyl phthalate (BBP) (0.1%), dibutyl phthalate (DBP) (0.1%) and diisobutyl phthalate (DIBP) (0.1%). 

37 OJ L 137, 4.6.2015, p. 10-12. 

38 For example, category 9 of Annex I, industrial monitoring and control instruments, came under the scope of RoHS in 
July 2017. Article 4(4)(e) exempts cables or spare parts for the repair, the reuse, the updating of functionalities or 
upgrading of capacity of industrial monitoring and control instruments placed on the market before 22 July 2017. 

14 

 
 
exemptions. Annex III exemptions can apply to all EEE categories, while Annex IV lists 
applications specific to medical devices and monitoring and control instruments. 

Article 5(1) defines the process and criteria whereby the European Commission includes 
or deletes EEE materials and components for specific applications in Annexes III and IV. 
This is the case where any of the following conditions is fulfilled: 

▪  elimination or substitution via design changes or materials and components which do 
not  require  any  of  the  materials  or  substances  listed  in  Annex  II  is  scientifically  or 
technically impracticable; 

▪  substitutes are not reliable; and 

▪ 

the  total  negative  environmental,  health  and  consumer  safety  impacts  caused  by 
substitution  are  likely  to  outweigh  the  total  environmental,  health  and  consumer 
safety benefits. 

The availability of substitutes and the socioeconomic impact of substitution must also be 
taken  into  account.  Decisions  on  the  duration  of  any  exemptions  take  into  account  any 
potential adverse impacts on innovation. Life cycle thinking on the overall impacts of the 
exemption should apply, where relevant. Amendments can only be made to Annexes III 
and IV through individual delegated acts. 

When assessing whether to  add, amend or delete exemptions, the Commission  requests 
external experts to evaluate exemption requests from industry and to assess if any of the 
criteria in Article 5(1)(a) is met. The exemption assessment consists of different phases, 
including  a  clarification,  consultation,  evaluation  and  reporting  phase.  In  the  process, 
several  questionnaires  are  usually  shared  and  at  least  one  public  online  consultation  is 
conducted,  involving  applicant,  stakeholders  and  sector  experts.  Technical  discussions 
are  held  at  this  stage  to  ensure  transparency  for  all  stakeholders.  At  the  end  of  the 
including 
process, 
recommendations that the Commission considers when taking its decision. 

the  Commission’s  consultants  provide 

it  with  a 

report 

The Annexes to the RoHS Directive currently contain 18 pages of time-limited detailed 
exemptions (as of December 2022)39, covering many different technical applications e.g. 
lighting  equipment,  medical  devices,  basic  electrical  components  and  lead-containing 
alloys used in EEE. Some exemptions have expired but remain for sake of clarity in the 
Annexes  with  their  expiry  date.  Over  time,  exemptions  that  previously  covered  a  wide 
scope of applications have been made more specific and, where possible, their scope has 
been limited to certain applications for which alternatives are not available or practical. 
This  gives  effect  to  a  requirement  reflected  in  Recital  19  to  the  Directive  according  to 
which,  ‘Exemptions  from  the  restriction  for  certain  specific  materials  or  components 
should be limited in their scope and duration, in order to achieve a gradual phase-out of 
hazardous substances in EEE, given that the use of those substances in such applications 
should become avoidable.’ As a result, the technical complexity and level of detail of the 
exemptions have increased over time. 

39 Some older exemption entries do not show an expiry date but have one based on the articles of the Directive. 

15 

 
 
 
2.3.4  Declarations of conformity and CE marking 

The  main  obligation  in  Article 4(1)  of  the  RoHS  Directive  is  incumbent  upon  the 
manufacturer of an EEE, defined40 as ‘any natural or legal person who manufactures an 
EEE  or  who  has  an  EEE  designed  or  manufactured  and  markets  it  under  his  name  or 
trademark.’ Manufacturers are to draw up the required technical documentation and carry 
out the internal production control procedure41. 

When  these  procedures  demonstrate  that  EEE  complies  with  the  requirements, 
manufacturers draw up an EU declaration of conformity42 and affix the CE marking43 to 
the finished product. Additional obligations concerning record keeping and identification 
of EEE are also applicable. In the absence of evidence to the contrary, EEE bearing the 
CE marking are presumed to comply with the Directive. 

40 Article 3(6) of the RoHS Directive. 

41 Article 7 of the RoHS Directive. 

42 In accordance with Article 13 of the RoHS Directive. 

43 In accordance with Articles 14 and 15 of the RoHS Directive. 

16 

 
 
 
 
3  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? 

3.1  Transposition of the RoHS Directive and delegated acts 

Under Article 25 of the RoHS Directive, Member States must, by 2 January 2013, have 
adopted  and  published  the  laws,  regulations  and  administrative  provisions  necessary  to 
comply  with  the  Directive  and  then  communicated  those  provisions  to  the  European 
Commission.  All  Member  States  have  adopted  legislation  transposing  the  RoHS 
Directive into national law and most Member States have adopted legislation specifically 
focusing on hazardous substances in EEE. 

The RoHS Directive has to date been amended by 80 Commission delegated directives44, 
many of which amend Annexes III and IV. In the consultation, many Member States said 
that amendments  to  the  Directive  are transposed through subsequent  amendment of the 
national  legislation,  with  some  referring  to  ‘dynamic  links’  in  their  national  legislation 
(see  chapter  4.1.5).  Private  stakeholders,  mainly  from  the  electrical  and  electronic 
business community, expressed concerns about the RoHS’s effectiveness as a directive, 
rather  than  a  regulation,  which  is  seen  as  a  more  efficient  legal  form  for  handling  the 
frequent updates. This issue is explored further in Section 4. 

3.2 

Implementation and enforcement 

The Directive’s provisions on market surveillance are central to  its implementation and 
enforcement.  Article 18  requires  Member  States  to  carry  out  market  surveillance  in 
accordance  with  Articles 15  to 29  of  Regulation  (EC)  No 765/2008  as  amended  by 
Regulation (EU) 2019/102045.  These Articles  (Chapter  III of the  Regulation) outline the 
EU’s  market  surveillance  framework  and  checks  on  products  entering  the  internal 
market. They require that each Member State designate a national authority which will be 
tasked with surveillance of the national market (here on the basis of the RoHS Directive 
and national implementing legislation). 

The RoHS Directive refers in various provisions to the ‘competent national authority’, to 
whom economic operators46 should send information and documentation to demonstrate 
that EEE complies with the Directive’s requirements (Articles 7, 8, 9 and 10). 

Member States use different measures for checking compliance with the RoHS Directive. 
Checking  that  marking  obligations  are  complied  with  is  the  simplest  and  most 
economical way. This document-based check typically focuses on checking that the CE 
marking is present and has been correctly applied, and that the declaration of conformity 
is  present  and  valid.  Although  only  four  Member  States  clearly  said  they  use  this 
approach  to  market  surveillance  for  the  RoHS  Directive,  further  feedback  on  non-

44 As at December 2022. 

45  Regulation  (EU)  2019/1020  on  market  surveillance  and  compliance  of  products  amended  Regulation 
(EC)  No 765/2008,  replacing  Articles  15  to  29  of  Regulation  (EC)  No 765/2008  by  corresponding 
provisions. These amendments are applicable from 16 July 2021. 

46  According  to  Article 3(10)  of  the  Directive,  ‘economic  operators’  means  the  manufacturer,  the 

authorised representative, the importer and the distributor. 

17 

 
 
 
 
 
conformity  issues  suggested  that  this  approach  is  widely  used  among  Member  States. 
More  complex  types  of  testing  involve  the  use  of  X-ray  fluorescence  (XRF) 
spectrometers47 by a number of Member States48, and, for certain substances, laboratory 
testing, used by at least five Member States49. 

An administrative cooperation (AdCo) group supports enforcement of the Directive and 
helps  to  ensure  it  is  applied  consistently50.  The  group  sometimes  organises  market 
surveillance joint actions, among other activities. For instance, in 2016, the RoHS AdCo 
group  conducted  a  joint  project  on  USB  cables  and  contacts51.  It  aimed  to  assess 
compliance levels and to promote harmonised enforcement of the RoHS Directive across 
Europe.  Results  of  risk-based  checks  have  shown  that,  of  the  157  products  tested,  38 
(24%)  contained  excessive  levels  of  an  RoHS-restricted  substance,  mainly  lead  in 
solders.  Technical  documentation  was  inspected  for  18  products,  and  found  to  be  non-
compliant for 8 (44%). Labels on 109 of the 157 products were checked and 67 of these 
(61%)  were  non-compliant.  Similar  results  were  obtained  in  2019  in  tests  on  products 
with  LED  lamps  and/or  batteries;  25%  of  the  products  tested  contained  more  than  the 
tolerated  maximum  concentration  of  an  RoHS-restricted  substance52.  Appropriate 
enforcement  measures  were  taken  by  the  relevant  national  authorities.  Additionally, 
economic operators were informed of these results and referred to guidance on working 
preventively to comply with the requirements in the RoHS Directive. 

Private  stakeholders  expressed  the  view  that  the  overall  level  of  compliance  with  the 
Directive  is  satisfactory,  and  that  its  implementation  mechanisms  function  as  intended. 
However,  enforcement  activities  reveal  high  non-compliance  levels  for  some  product 
categories.  In  addition,  market  surveillance  authorities  report  that  requests  for  further 
evidence  of  compliance  from  economic  operators  in  the  supply  chain  are  often 
unsuccessful. 

In the year 2012, the import of EEE was 2,75 times higher than the export of EEE from 
the  EU53.  Between  2014  and  2020  the  monetary  import  of  EEE  increased54.  This  is 
relevant as market surveillance authorities reported practical difficulties in enforcing the 
provisions in cases of non-compliant imported EEE and in contacting authorities outside 

47  XRF  spectrometers  are  elemental  analysers  designed  to  detect  inorganic  elements  such  as  chromium,  bromine, 
cadmium,  mercury  and  lead,  in  homogeneous  polymeric  materials.  The  particular  advantage  of  ‘hand  held’  or 
‘portable’ XRF instruments is that they enable analytical measurements to be taken in situ. The operator can then 
make a more informed decision on what, if anything, to investigate in subsequent laboratory tests. 

48 Czechia, Finland and Sweden. 

49 Greece, Lithuania, Austria, Finland and Sweden. 

50 European cooperation on market surveillance takes place through informal groups of market surveillance authorities, 
called administrative cooperation (AdCo) groups. The members of these groups are appointed by Member States 
and represent national authorities responsible for market surveillance in a given sector. 

51  RoHS  AdCo  2016  joint  project  on  USB  cables  and  contacts,  https://www.kemi.se/en/publications/enforcement-

reports/2016/enforcement-12-16-rohs-adco-joint-project-2016. 

52  RoHS  AdCo  2019  joint  project  on  LED-lamps  and  batteries,  https://www.kemi.se/en/publications/enforcement-

reports/2020/enforcement-14-20-rohs-adco-joint-project-2019. 

53 In tonnes - https://www.eea.europa.eu/data-and-maps/figures/imports-and-exports-of-electrical  

18 

 
 
 
 
 
of the EU, despite the obligation that the economic operator needs to be established in the 
EU (Article 4(1) of Regulation (EU) 2019/1020). 

According  to  an  impact  assessment  on  product-related  harmonisation  legislation55 
published  in  2017,  an  estimated  23%  to  28%  of  EEE  products  did  not  comply  with 
RoHS. The study also analysed non-compliance reports available in the EU Safety Gate 
Database56 for 2013-2020, from which the following key points could be extrapolated for 
the RoHS Directive. 

1.  The  presence  of  lead  in  EEE  is  the  most-frequently  mentioned  reason  for  non-

compliance. 

2.  For any given year, Sweden has the highest number of reports. This might be because 
Sweden  takes  a  more  stringent  approach  to  market  surveillance  than  other  Member 
States, or because it has a greater propensity to file reports. 

3.  China is by far the most cited country of origin for RoHS-non-compliant goods. 
4.  The number of non-compliance reports submitted in 2019 is significantly higher than 
for all other years. This might reflect one or a combination of the following factors: 
-  a change in market surveillance approaches in Member States; 
-  a change in reporting approaches in Member States; and 
-  all else being equal, an increase in the number of non-compliant products. 

Different  market  surveillance  approaches  and  methods  of  reporting  non-compliance 
might bias the available data. Therefore, it is not possible to draw strong conclusions on 
the  level  of  compliance  with  the  Directive.  In  this  regard,  efforts  are  being  made  to 
harmonise methodologies and criteria for assessing risks and to strengthen consistency in 
different market surveillance activities under Regulation (EU) 2019/1020 

3.3 

Interactions with other EU policies and legislation 

The  RoHS  Directive  has  strong  links  to  chemicals  legislation  like  the  REACH 
Regulation or the POPs Regulation. Substances can only be considered for inclusion on 
the  list  of  restricted  substances  if  inclusion  would  be  in  line  with  existing  legislation. 
Amendments to the list of exemptions should not weaken the protection level afforded by 
the REACH Regulation. Those points are to be regularly taken into account by reviewing 
the list  of restricted substances or the  exemption  list.  In addition,  scope exclusions and 
deviations  from  substance  restrictions  as  the  ‘repair  as  produced’  principle  required 
special consideration to avoid inconsistencies between the different legislations. 

The RoHS Directive is part of EU harmonisation legislation for manufactured products, 
and is therefore covered by its uniform framework for market surveillance. 

54   Trade by commodity and NACE Rev. 2 activity [EXT_TEC05__custom_2012768] 

55  

Impact assessment accompanying the proposal for a regulation of the European Parliament and of the Council 
laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on 
products (2017) https://eur-lex.europa.eu/resource.html?uri=cellar:105e4f9b-e4b1-11e7-9749-
01aa75ed71a1.0001.02/DOC_1&format=PDF. 

56   The Safety Gate system enables quick circulation of information about non-food dangerous products among the 

national authorities responsible for product safety in the single market countries. 

https://ec.europa.eu/safety-gate-alerts/screen/webReport 

19 

 
 
 
 
The  chemicals  strategy  for  sustainability  promotes  a  safe  and  sustainable-by-design 
approach  and  non-toxic  material  cycles,  stating,  ‘[…]  it  is  necessary  to  ensure  that 
substances of concern in products and recycled materials are minimised. As a principle, 
the  same  limit  value  for  hazardous  substances  should  apply  for  virgin  and  recycled 
material.  However,  there  may  be  exceptional  circumstances  where  a  derogation  to  this 
principle  may  be  necessary.  This  would  be  under  the  condition  that  the  use  of  the 
recycled  material  is  limited  to  clearly  defined  applications  where  there  is  no  negative 
impact on consumer health and the environment, and where the use of recycled material 
compared to virgin material is justified on the basis of a case-by-case analysis.’ 

Closely  linked  to  the  substance  restrictions  under  the  RoHS  Directive  are  ecodesign 
requirements  laid  down  by  the  Ecodesign  Directive57  and  its  implementing  measures. 
Some products (e.g. fluorescent lamps) and their energy consumption are closely related 
to the use of hazardous substances and thus to RoHS requirements. To further reduce the 
negative environmental impacts of products over their lifetime, the Commission proposal 
for  an  ecodesign  for  sustainable  products  regulation  (ESPR)  would  broaden  ecodesign 
requirements  and  extend  their  scope58.  Adoption  of  the  proposed  regulation  and 
implementation  through  product–specific  delegated  acts  will  be  of  relevance  to 
interaction with the RoHS Directive. 

Like the WEEE Directive, as explained in detail above, the RoHS Directive also interacts 
with many pieces of EU legislation on waste, such as Directive 2000/53/EC (‘End-of-life 
Vehicles Directive’). 

57 Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a 
framework  for  the  setting  of  ecodesign  requirements  for  energy-related  products  (OJ  L  285, 
31.10.2009, p. 10-35). 

58 COM(2022) 142 final. 

20 

 
 
 
 
4  EVALUATION FINDINGS 

The  Better  Regulation  Guidelines  require  evaluations  to  assess  the  effectiveness, 
efficiency,  coherence,  relevance  and  EU added  value.  To  operationalise 
the 
assessment,  an  evaluation  matrix  was  developed,  which  breaks  the  criteria  down  into 
evaluation  questions  (see  Annex  III).  Results  of  the  assessment  are  presented  below, 
structured around three main guiding questions covering all the criteria. 

•  To  what  extent  was  the  RoHS  Directive  successful  and  why?  (Effectiveness, 

efficiency and coherence) 

•  How did the EU intervention make a difference? (EU added value) 
• 

Is the intervention still relevant? (Relevance) 

4.1  To what extent was the RoHS Directive successful and why? 

Overall response 

The  RoHS  Directive  helped  to  reduce  the  relative  amount  of  hazardous  substances  in 
EEE placed on the EU market and thus to protect human health and the environment. It 
contributed to WEEE treatment by reducing the level of hazardous substances per item of 
EEE  in  that  waste  stream.  Consequently,  there  is  reason  to  believe  that  waste 
management  processes  overall  have  become  safer,  although  only  limited  quantitative 
evidence  is  currently  available.  The  reduction  in  hazardous  substances  in  WEEE  is 
partially counterbalanced by the increasing volumes of WEEE generated in Europe. 

Furthermore,  by  providing  for  harmonised  substance  restrictions  at  EU  level,  the 
Directive produced economic benefits by creating a level playing field for businesses in 
the internal market, increasing legal certainty, and in some cases stimulating innovation 
through substitution. The Directive has also paved the way for RoHS-like legislation to 
be developed around the world. 

As for costs arising from the Directive, most appear to be linked to the exemption system 
and  product  development  to  comply  with  substance  restrictions.  However,  businesses, 
and competent authorities in the Member States, found it difficult to dissociate the costs 
for RoHS from the costs linked to other compliance or enforcement activities related to 
EEE. 

Two  coherence  issues  were  identified  for  the  Directive,  both  closely  related  to  each 
other: 

•  procedures  for  deciding  on  exemptions  and  review  and  amendment  of  the  list  of 
restricted  substances,  which  were  seen  to  have  led  to  inefficiencies  and  administrative 
burden; 

•  concerns  regarding  synergies  and  consistency  in  application  between  the  RoHS 
Directive and related legislation (e.g. REACH, Ecodesign), including concerns about the 
coherence of approaches to substance evaluation. 

The success of legislation is measured largely by how well it meets its objectives. In this 
respect, the evaluation sought to identify: 

▪ 

▪ 

the  factors  driving  or  hindering  the  RoHS  Directive’s  progress  in  achieving  its 
objectives (the Directive’s effectiveness); 
the extent to which the needs of the Directive are met in the most cost-effective ways 
(the Directive’s efficiency) and with the least possible burden; and 

21 

 
▪  whether  the  Directive  is  internally  coherent  and  functions  well  in  conjunction  with 

other relevant legislation (the Directive’s coherence). 

The main conclusions of this analysis are set out below. 

4.1.1  The  RoHS  Directive  achieved  its  primary  objective  of  restricting  and  thereby 

reducing the use of certain hazardous substances in EEE 

The  evaluation  study  findings  suggest  that  the  RoHS  Directive  contributed  to  a 
reduction in hazardous substances in EEE put on the EU market. 

The  evaluation  study  contained  an  analysis  assessing  the  scale  of  the  reduction  in 
hazardous  substances  in  EEE.  Some  assumptions  had  to  be  made  here,  and  the  used 
model was limited by the availability of quantitative data on the content and reduction in 
hazardous  substances  in  EEE  (see  also  chapter  1.5.2).  The  analysis  assumed  that 
economic operators in question complied with the Directive, even though as indicated in 
Chapter  3.2  there  may  be  a  certain  level  on  non-compliance  in  the  EEE  sector,  which 
would result in higher amounts of hazardous substances in EEE. 

As the impact of other legislative developments and instruments, such as the introduction 
of  the  REACH  Regulation,  could  not  be  quantified,  the  reduction  in  hazardous 
substances in EEE cannot be attributed to RoHS alone. As an example, there are several 
acts restricting lead (e.g., in packaging59, batteries60, vehicles61), but they do not directly 
restrict hazardous substances in EEE although their positive effect could indirectly result 
from  the  fact  that secondary material  streams  used for EEE  manufacturing contain less 
lead  due  such  restrictions.  Other  pieces  of  legislation  do  not  directly  restrict  hazardous 
substances on environmental reasons but e.g. by introducing migration limits (e.g., under 
the  Directive  2009/48/EC62)  it  is  reasonable  to  expect  a  reduction  of  hazardous 
substances in articles including EEE. Besides legal requirements, it is expected that other 
initiatives/measures  as  labels/certificates,  requirements  for  the  public  sector,  financial 
incentives  or internal  company requirements  have a significant  impact on the reduction 
of hazardous substances in EEE (see also the second support study).  

The quantitative analysis in the evaluation study estimates that, between the introduction 
of  RoHS 1  in  2003  and  2016,  restricted  substances  (cadmium,  lead  and  mercury  only) 
were reduced by around two thirds63. While the precise scale of the reduction cannot be 

59   European  Parliament  and  Council  Directive  94/62/EC  of  20  December  1994  on  packaging  and 

packaging waste - OJ L 365, 31.12.1994, p.10. 

60   Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries 
and  accumulators  and  waste  batteries  and  accumulators  and  repealing  Directive  91/157/EEC  -  OJ  L 
266, 26.9.2006, p.1. 

61   Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of 

life vehicles  - OJ L 269 21.10.2000, p. 34. 

62   Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of 

toys - OJ L 170, 30.6.2009, p. 1–37 

63 As presented in Appendix II to the evaluation study. 

The baseline estimations are based on the limited data available on the concentration of hazardous substances in a 
selection of products. These products and their concentrations have been used as proxies for their entire category. 

22 

 
 
determined  with  certainty  and  estimates  are  not  precise  measurements,  the  finding  that 
the  concentration  of  hazardous  substances  in  EEE  declined  with  introduction  of  the 
RoHS 1 Directive is deemed valid. 

For the other substances, i.e. hexavalent chromium, PBDEs, PBB and the phthalates, the 
second support study indicates a reduction in EEE over the years. Similar to the previous 
findings,  it  cannot  be  attributed  to  the  RoHS  Directive  alone  as  many  substances  were 
about to be phased-out by other regulatory pressure and changed demands on the market. 

The evaluation study also indicated that the average lifespan of EEE has decreased64. For 
instance,  the  lifespan  of  personal  computers  fell  by  more  than  50%  from  4-6  years  in 
1997 to 2 years in 200565. In combination with the increase in electrified equipment (e.g. 
for  ‘smart  homes’),  this  suggests  that  the  number  of  products  in  the  WEEE  stream  has 
been increasing, a finding supported by other sources66, 67,. For the EU, the WEEE stream 
has a current annual growth rate of 2%68.  

The increasing volume of WEEE generated in Europe (see also 4.2.1.) is included in the 
quantitative  analysis  and  it  should  be  emphasised  that  this  significantly  offset  the 
reduction in hazardous substances in WEEE in total. 

Another  shortcoming  in  the  quantitative  analysis  is  that  the  time-limited  exemptions 
under the Directive were not considered. The exemptions cover a significant amount of 
hazardous  substances.  In  the  second  support  study  a  rough  estimation  of  the  most 
relevant  exemptions  for  lead  indicates  a  quantity  of  over  10 000  tonnes69,  which  shows 
the relevance. 

Looking  at  five  applications,  mostly  relevant  to  categories  1-7  and  10  of  Annex  I, 
exempted since the adoption of the RoHS 1 Directive, valid for three different substances 
and subsequently renewed, an estimate suggests that for many exemptions, the volume of 
hazardous substances covered has fallen over time, but it was unclear whether this was 
related  to  the  exemption  system  under  the  RoHS  Directive.  The  amount  of  mercury  in 
fluorescent lamps has been reduced over the years, partly due to the narrowing down the 
scope  of  the  relevant  exemptions.  For  one  application  concerning  lead,  there  was  no 
decrease  in  volume  over  the  last  20  years.  For  another  application,  no  reliable 
information was available on the volume of hazardous substance70. 

64 Evaluation study: with latest estimates in 2012/2013. 

65 Habib et al., ‘What gets measured gets managed – does it? Uncovering the waste electrical and electronic equipment 

flows in the European Union’, Resources, Conservation & Recycling 181 (2022), Article 106222. 

66 Global E-waste Monitor UNU-IAS, 2017. 

67 Eurostat 2020 – WEEE by waste management operations. 

68 COM(2019) 640 final. 

69 Study to support the assessment of impacts associated with the general review of Directive 2011/65/EU 
(RoHS Directive) - https://op.europa.eu/en/publication-detail/-/publication/b9188764-f465-11ed-a05c-
01aa75ed71a1/language-en/format-PDF/source-286516984  

70   Study  underpinning  the  assessment  of  impacts  associated  with  the  general  review  of  Directive 
2011/65/EU  (RoHS  Directive)  -  https://op.europa.eu/en/publication-detail/-/publication/b9188764-
f465-11ed-a05c-01aa75ed71a1/language-en/format-PDF/source-286516984. 

23 

 
 
The introduction of the ‘open scope’ had an impact in further reducing the total amount 
of hazardous substances in EEE. According to stakeholders from the medical sector the 
reduction in hazardous substances in category 8 (medical devices) was small due to many 
justified exemptions. This is plausible as on the one hand, many exemptions for medical 
devices expired71 and on the other, many new exemptions are listed in Annex IV of the 
Directive.  For category 9 (monitoring and control instruments), the relevant association 
estimated  that  most  hazardous  substances  (around  99%)  were  avoided  comparing  the 
years 2004 and 2019. This could not be confirmed in the evaluation study.  

For  category  11,  a  case-study  on  the  United  Kingdom  suggests  that  e.g.  200  kg  lead, 
110 kg PBDE and 100 kg hexavalent chromium are saved between 2019 and 2025 by the 
inclusion of category 11 in the scope of the Directive.  

A decreasing trend of the amount of hazardous substances was suggested by stakeholder 
during the consultation  activities.  And in  the  OPC, most  respondents  among  the expert 
stakeholders thought that the RoHS Directive was helping to reduce the use of hazardous 
substances in EEE produced both in and outside the EU (Figure 1). 

Figure 1: Expert OPC responses: reduction in use of hazardous substances in EEE (N=101) 

In the same OPC, Member States’ representatives (N=15, 70% of all responses received) 
also gave a positive assessment of the effectiveness of the Directive. However, while in 
general most respondents thought RoHS had reduced the use of hazardous substances in 
EEE, they highlighted that it was difficult to provide a precise quantified estimate due to 
a lack of comprehensive data on the concentrations of hazardous substances in EEE. 

As to which substances were reduced the most, expert stakeholders from businesses and 
associations (N=86, 75%) indicated in the OPC that the RoHS Directive had particularly 
impacted on the use of lead, mercury and hexavalent chromium in EEE, but less on other 
hazardous substances covered (see also Annex V).  

71   Evaluation Study – For example, exemptions No. 21, 24, 28, 30, 32, 33 IIa, 38 under Annex IV  

24 

 
 
 
 
 
The quantitative analysis, with estimates for lead, mercury and cadmium, found that lead 
accounted for the largest part of the reduction. This is in line with lead’s broad range of 
electrical and electronic applications, though some applications (e.g. in solders or alloys) 
are  thought  to  be  still  covered  by  time-limited  exemptions.  For  lead  and  mercury,  the 
findings of the project ‘urban mine platform’ under the ProSUM Project72 confirmed that 
there had indeed been a reduction. However, it was found that the amount of cadmium 
placed  on  the  market  had  increased  in  recent  years  under  this  project,  which  conflicts 
with the results of the evaluation study. 

4.1.2  Achieving  a  reduction  in  hazardous  substances  is  expected  to  have  positive 

effects on human health and the environment. 

The complex correlations between a reduction of hazardous substances and the effects on 
human  health  and  the  environment  are  difficult  to  quantify.  Different  legislation 
contributes to those effects and there are, after all, cumulative health and environmental 
benefits, which are described in a study73. The following conclusions can be drawn as to 
the magnitude of the environmental effects concerning the RoHS Directive. 

▪  The  reduction  in  hazardous  substances  results  in  lower  levels  of  harmful  emissions 
during  WEEE  treatment  and  recycling  processes,  provided  the  WEEE  is  properly 
disposed of and treated. However, sound recycling practices need to be in place, so 
that emissions are carefully managed. Important requirements on limiting emissions, 
including emissions of restricted substances under RoHS, are laid down by Directive 
2010/75/EU74 and Directive 2008/105/EC75. 

▪  The average collection rate of WEEE in the EU was 45.9% in 202076, meaning that 
more than half of WEEE (around 4.7 Mt) was not properly collected and escaped the 
designated  waste  management  systems.  Of  this  amount,  some  was  recycled  under 
non-compliant  conditions  (1.12 Mt),  some  scavenged  for  valuable  components 
(0.64 Mt),  some  disposed  of  as  part  of  residual  waste  (0.6 Mt),  and  some  legally 
exported (0.29 Mt)77. The remaining WEEE (2.09 Mt) is unaccounted for,  including 
possibly illegally exported. 

▪  Waste  treatment  or  recovery  operations  not  specially  equipped  to  treat  WEEE  can 
have adverse  environmental impacts through higher emissions.  Once the substances 
are released in the environment, for instance via air, dust, or water, they can harm the 

72   http://www.urbanmineplatform.eu/composition/eee/elements.  

73  Study  on  the  cumulative  health  and  environmental  benefits  of  chemical  legislation  (2017): 

https://op.europa.eu/en/publication-detail/-/publication/b43d720c-9db0-11e7-b92d-
01aa75ed71a1/language-en  

74   Directive  2010/75/EU  of  the  European  Parliament  and  of  the  Council  of  24 November  2010  on  industrial 

emissions - OJ L 334 17.12.2010, p. 17. 

75  Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16 December  2008  on  environmental 

quality standards in the field of water policy - OJ L 348, 24.12.2008, p. 84. 

76  Measured  as  the  weight  of  WEEE  collected  relative  to  the  average  weight  of  electronic  equipment  put  on  the 
https://ec.europa.eu/eurostat/statistics-

i.e. 
market 
explained/index.php?title=Waste_statistics_-_electrical_and_electronic_equipment&oldid=556612; 

2017-2019.  See 

preceding 

years, 

the 

in 

3 

77   Considering 11 countries in Europe 

25 

 
 
ecosystem. For example, over time mercury emissions can bio-accumulate along the 
food chain and cause serious toxication.  A reduction in the hazardous substances in 
WEEE treated in this way can reduce those unwanted emissions and prevent adverse 
impacts. 

▪  Exported  WEEE  may  be  processed  using  inadequate  or  unsafe  WEEE  recycling 
techniques  that  do  not  meet  the  same  protection  standards  as  those  in  the  EU.  In 
particular, there is a high risk that WEEE exported illegally from Europe will cause 
severe damage to the environment and to human health, for example when processed 
in small workshops using very basic methods such as manual disassembly and open 
incineration without emission-control techniques. 

As  for  the  effects  on  human  health,  the  evaluation  study  came  to  the  conclusion  that 
both  waste  workers  and,  to  a  lesser  extent,  consumers  are  generally  exposed  through 
three different routes: inhalation, skin contact or ingestion78. There is a risk that improper 
use or accidents (e.g. breaking of mercury containing discharge lamps) can lead to health 
damage.  Table  1  summarises  the  possible  health  damages  from  excessive  exposure  to 
four  RoHS  substances  and  also  includes  a  reference  to  the  relevant  EU  legislation 
defining exposure limits of workers. 

Table  1:  Potential  health  damage  and  occupational  exposure  limits  of  hazardous 
substances (Source: evaluation study) 
Potential health damage 

Occupational exposure limit (EU) 

Substance79 
Cadmium  and 
inorganic 
its 
compounds 
048-001-00-5 

Harmful if inhaled – H332. 
Harmful  in  contact  with  skin  – 
H312. 
Harmful if swallowed – H302. 

8  hours  limit  value:  0.001  mg/m³ 
(inhalable fraction) 
Transitional measures until 11.7.2027 
Binding  occupational  exposure  limit 
value 
(Directive  2004/37/EC  on  carcinogens 
or mutagens at work) 
8 hours limit value: 0.005 mg/m³ 
Transitional measures until 17.1.2025 
Binding  occupational  exposure  limit 
value 
(Directive  2004/37/EC  oncarcinogens 
or mutagens at work) 
8 hours limit value: 0.15 mg/m³ 
Binding  occupational  exposure  limit 
value 
(Directive 98/24/EC on risks related to 
chemical agents at work) 

Chromium(VI) 
compounds 
024-017-00-8 

May  cause  cancer  by  inhalation  – 
H350i. 
May cause an allergic skin reaction 
– H317. 

Lead 
082-001-00-6 

Harmful  if  swallowed  or  inhaled. 
H302 + H332. 
May  damage  fertility  or  the  unborn 
child – H360Df. 
May  cause  harm 
children – H362 (other lead entry) 
May  cause  damage 
through  prolonged  or 
exposure – H373. 

to  organs 
repeated 

to  breast-fed 

78 K. Grant, F.C. Goldizen, P.D. Sly, M.-N. Brune, M. Neira, M. van den Berg, et al. Health consequences of exposure 

to e-waste: a systematic review - The Lancet Global Health, 1 (6) (2013), pp. e350-e361. 

79 Index No & hazard statement code from the harmonised classification in Annex VI (Part 3, Table 3) to Regulation 
(EC) No 1272/2008 (CLP). The index No refers to the main chemical and  does not include  chemicals specified 
elsewhere in the Annex (unless indicated otherwise. 

26 

 
  
 
 
Mercury 
080-001-00-0 

Fatal if inhaled – H330. 
May  damage  the  unborn  child  – 
H360. 
Causes  damage  to  organs  through 
prolonged  or  repeated  exposure  – 
H372. 

8 hours limit value: 0.02 mg/m³ 
Recommended  indicative  occupational 
exposure 
(Directive 
2009/161/EU) 

value 

limit 

The evaluation study also found that workers in EEE manufacturing and recycling plants 
are more exposed than other people. For instance, in a 2014 study80 on workers’ exposure 
at  three  e-waste  recycling  plants  in  Sweden,  where  significantly  higher  levels  of 
chromium, lead and mercury were found in recycling workers than in other workers. 

A higher risk for workers is anticipated when WEEE is processed outside the designated 
waste management systems, as the presence of hazardous substances (see Table 1) is less 
evident  and/or  less  stringent  occupational  health  and  safety  measures  are  taken.  In 
addition, EU occupational requirements do not apply to exported WEEE. 

In  view  of  this  and  the  significant  amount  of  exported  WEEE,  it  is  worth  highlighting 
that, as reported in several studies81, the impact of the RoHS Directive on human health, 
especially on workers, is most visible outside the EU. 

The  stakeholders’  views  on  the  impact  of  workers’  health  are  divided.  Businesses  and 
industry associations pointed out that EU workers are not significantly impacted by the 
RoHS-induced  reduction  in  hazardous  substances  in  EEE,  as  numerous  measures  to 
protect  health  and  safety  standards  in  the  EU  were  already  in  place  (as  reported  in  the 
Table  1  above).  NGOs  highlighted  that,  regardless  of  measures  already  in  place,  the 
reduction  in  hazardous  substances  in  EEE  triggered  by  the  Directive  had  still  had  a 
positive  impact  on  the  health  of  workers  exposed  to  hazardous  substances  both  during 
manufacturing but also at the end of these products’ life. 

80  A.  Julander  et  al.,  ‘Formal  recycling  of  e-waste  leads  to  increased  exposure  to  toxic  metals:  An  occupational 
exposure study from Sweden’, Environment International, Volume 73, December 2014, Pages 243-251. 

81  K.A. Asante, T. Agusa, C.A. Biney, W.A. Agyekum, M. Bello, M. Otsuka, et al., Multi-trace element levels and 
arsenic speciation in urine of e-waste recycling workers from Agbogbloshie, Accra in Ghana, Sci Total Environ, 
424 (2012), pp. 63-73. 

27 

 
 
 
Figure  2: Member States’ survey responses  – Has the  safety of  electrical and electronic equipment 
for human health improved, stayed the same or declined over the last 10 years? (N=21) 

Figure  2  shows  that  for  products  produced  and  sold  in  the  EU,  around  half  of  the 
respondents (9 of N=21) agree that the health and safety aspects of EEE have improved 
in the last decade. 

One  example  concerned  the  positive  impact  on  workers’  health  in  the  mercury-added 
lamp  manufacturing  sector  where,  as  a  result  of  the  RoHS  Directive,  the  permitted 
mercury  content  in  the  manufacturing  of  fluorescent  lamps  was  reduced82.  Workers 
initially used to pour liquid mercury into the lamps, with around 50% loss and spillages 
occurring;  as  a  result,  the  workers  and  surrounding  workspace  would  become 
contaminated with mercury and exposed workers would be affected by mercuriosis. With 
the  maximum  allowed  quantity  reduced,  manufacturers  started  to  use  different 
techniques,  such  as  strips,  pellets  or  amalgam,  where  the  mercury  would  be  contained 
and  eventually  released  within  the  lamps;  as  a  result,  no  mercury  spillages  and  high 
exposure  would  occur.  However,  other  legislation,  such  as  occupational  health 
regulations, have certainly also made a significant contribution to this effect. 

4.1.3  The RoHS Directive has contributed to the environmentally sound recovery and 

disposal of waste EEE 

If  the  amount  of  hazardous  substances  in  EEE  has  decreased  over  time,  it  can  also  be 
concluded  that,  at  the  end  of  the  EEE life  cycle,  such  substances  entered  the  waste 
stream in smaller quantities. For instance, the evaluation study analysis83 corroborating 
Eurostat  data  on  EEE  waste  streams  with  data  provided  by  the  Urban  Mine  Platform 
database84, concluded that the amount of lead contained in WEEE generated in the EU85 

82 Many respective exemptions were not extended in the last review and are due to expire in 2023. 

83 Appendix III. 

84 http://www.urbanmineplatform.eu/composition/eee/elements 

85 Including the United Kingdom. 

28 

 
 
 
has  been  decreasing  since  2011,  from  around  70 kilotons  to  28 kilotons  in  2020. 
Knowing  that  the  number  of  products  in  WEEE  streams  has  increased  in  the  last  few 
years, it is therefore reasonable to assume that the decrease in lead seen in WEEE is due 
to a decrease in the amount of lead in individual items of EEE. 

As  for  the  impact  of  the  RoHS  Directive  on  the  recovery  and  disposal  processes 
applied  to  waste  EEE,  disentangling  the  effects  of  the  two  complementary  pieces  of 
legislation,  WEEE and  RoHS  Directive,  on waste EEE treatment  is  not  straightforward 
(e.g.  the  WEEE  Directive  identifies  a  set  of  materials  and  components  of  EEE  that 
should receive selective treatment, while the RoHS Directive identifies the substances in 
EEE). Overall, however, it can be concluded that the RoHS Directive has had an impact 
on  waste  EEE  treatment  beyond  the  requirements  of  the  WEEE  Directive  as  it 
contributed to reduce the amount of hazardous substances in WEEE. 

The  amount  of  WEEE  being  collected  and  treated  is  increasing  (see  Figure  3).  The 
WEEE Directive and the RoHS Directive have contributed to this positive trend. As the 
RoHS  Directive  has  driven  down  the  amounts  of  hazardous  substances  in  EEE,  the 
concentrations  in  mixed  WEEE  have  diminished  too.  These  material  streams  can  more 
easily meet product requirements (e.g. under the REACH Regulation or POP Regulation) 
and thus be recycled. 

Figure 3: EEE put on the market and WEEE collected and treated (in thousand tonnes), EU 28 

The  RoHS  Directive  also  contributes  to  the  objectives  of  the  circular  economy. 
Article 4(4) and 4(5) of the Directive contain provisions for cables and spare parts, which 
are  excluded  from  the  substance  restrictions.  Additionally,  time-limited  exemptions  in 
Annexes III and IV provide another possibility for ensuring the continued availability of 
spare parts for older devices that depend on them. This helps to avoid premature end of 
life for EEE. However, the provisions, some of which are due to expire, are not clearly 
summarised in one comprehensible paragraph, and might need to be updated in view of 
the new objectives. 

4.1.4  By introducing harmonised restrictions, the RoHS Directive has created a level 
playing  field  for  all  manufacturers,  thus  effectively  contributing  to  the 
functioning of the internal market 

its 
The  evidence  gathered,  mostly  from 
implementation  and  from  the  consultation  responses,  suggests  that  RoHS  introduced  a 

legal  framework  and 

the  established 

29 

 
 
harmonised set  of  rules  for establishing  a level  playing field  for the movement  of EEE 
across Europe. All Member States have adopted legislation which transposes RoHS into 
national  law.  Harmonised  application  of  the  Directive  was  further  enhanced  by  the 
alignment  of  the  Directive  with  the  New  Legislative  Framework  (NLF)86  whereby 
RoHS 287  introduced  requirements  regarding  CE  marking,  conformity  assessment  and 
other obligations on economic operators. Uniform application of general provisions and 
harmonised  implementation  facilitate  a  consistent  framework  for  different  product 
regulations.  This  makes  the  rules  easier  to  understand,  increases  legal  certainty  and 
supports the smooth functioning of the internal market. 

Also  worth  mentioning  here  is  the  process  of  reviewing  and  amending  the  list  of 
restricted substances in Annex II to the Directive through delegated act, for example, on 
the basis of a proposal from a Member State. This process provides a means of keeping 
up with the need for further harmonisation. 

Findings from the OPC confirmed the positive contribution the Directive has had on the 
functioning  of  the  internal  market.  Similarly,  in  the  targeted  survey  of  Member  State 
authorities, 55% agreed that RoHS contributed to free movement of EEE in the EU. 

Figure 4; Expert OPC responses: Free movement of EEE in the EU (N=101) 

However,  during  the  stakeholder  workshop  organised  as  part  of  the  evaluation  study, 
several stakeholders from Member States and from industry expressed concerns about the 
administrative burden linked to the transposition of the delegated directives amending the 
RoHS  Directive.  The  workshop  participants  asked  whether  another  form  of  legal 
instrument, i.e. a regulation, would help reduce this burden.  

86 New legislative framework, consisting of Regulation (EC) 765/2008 and Decision 765/2008/EC, as already outlined 

in Section 3 of the document. 

87 There were no such obligations at the EU level under RoHS 1 Directive. 

30 

 
 
 
 
 
 
Any  amendments  made  to  the  legislation  through  delegated  directives  concerning  the 
exemptions  in  Annexes  III  and  IV  requires  resources  from  the  Member  States  to 
transpose the provisions into national law and to notify the Commission of the national 
rules. There is a risk that legal uncertainties can arise concerning content and timing (e.g. 
different adoption dates within the transposition period). If the Directive were converted 
into a regulation, any changes to the regulation would apply directly. Follow-up work in 
the  form  of  transposition  would  be  significantly  reduced,  both  for  Member  State 
administrations  and  for  the  Commission  (see  also 4.1.6).  However,  this  has  to  be 
weighed  against  the  Member  States’  interest  to  integrate  flexibly  the  remaining 
provisions into their existing legal systems.  

4.1.5  Regulatory benefits counterbalance the regulatory costs 

As  evidenced  from  the  above  effectiveness  analysis,  the  RoHS  Directive  has  produced 
wider environmental and health benefits, even though other initiatives contributed to the 
same  objective.  For  example,  it  has  reduced  damage  to  the  environment  and  human 
health,  generated  economic  benefits,  levelled  the  playing  field  for  businesses  in  the 
internal market and created legal certainty. Table 2 below summarises the assessment of 
the regulatory  benefits  that  stem from  and can  be attributed to  the RoHS  Directive.  It 
has  proved  difficult  to  quantify  the  monetary  benefits  as  they  mainly  relate  to  the 
protection of the human health and the environment. 

Table 2: Assessment of the benefits of the RoHS Directive 

Benefit 
Environmental benefits 
Avoided  emissions  of 
hazardous 
substances 
from WEEE 

The  reduction  in  hazardous  substances 
in EEE results in lower environmentally 
damaging  emissions  during  WEEE 
recycling processes.  

Improved 
of EEE 

recyclability 

The  RoHS  Directive  has  led  to  a 
reduction  in  hazardous  substances  used 
in  EEE  and  consequently  in  WEEE 
(with  a  time  lag  depending  on  the 
product lifetime). Material streams from 
WEEE are less contaminated by certain 
the 
hazardous 
materials easier to recycle. 

substances,  making 

Assessment 

impact 

Achieved  to  some  extent. 
The 
differs 
depending  on  the  recycling 
practices  used  in  Europe 
compared 
to  developing 
countries.  Non-compliant 
products  can  reduce 
the 
effect.  Overall, 
positive 
had 
assessed 
have 
to 
positive 
the 
environment  in  the  EU  and 
third  countries  where 
in 
WEEE is processed. 
Achieved. 

impacts  on 

Contribution  to  circular 
economy 

The  RoHS  Directive  promotes  the  use 
of  certain  spare  parts  and  the  reuse  of 
certain recovered spare parts to make it 
easier to repair EEE. 

Achieved  to  some  extent.  
Industry  applies  respective  
exemptions.  

Health benefits 

31 

 
 
 
 
 
in 

Benefit 
the 
Reduction 
exposure  of  hazardous 
substances  for  workers 
in 
and 
production 
WEEE recycling plants 

Fewer  negative  health 
effects for consumers 

The  reduction  in  hazardous  substances 
in EEE triggered by the Directive had a 
positive impact on the health of workers 
exposed to hazardous substances during 
manufacturing and especially at the end 
of life of these products. 
The chance that consumers are exposed 
to  hazardous  substances  decrease  with 
the  reduction  in  hazardous  substances 
contained 
the 
restrictions  under  RoHS  have  had  a 
positive 
the  health  of 
consumers. 

in  EEE.  Therefore, 

impact  on 

Market efficiency benefits 

Proper  functioning  of 
the internal market 

Increase in innovation 

The  RoHS  Directive  has  made  a 
positive  contribution  to  the  functioning 
of  the  internal  market  by  creating  a 
level playing field and thus ensuring the 
free  movement  of  EEE  on  the  EU 
market. 
The  RoHS  Directive  has  had  a  positive 
to  substitute 
innovation 
impact  on 
restricted  substances.  In  some  cases, 
time-limited  exemptions  triggered  the 
innovation  process.  In  others,  when 
innovation  was  already  underway,  the 
RoHS  Directive 
time 
needed to complete the process. 

reduced 

the 

Assessment 

Achieved.  The  benefits  do 
not differ by product group. 
Overall,  assessed  to  have 
had  positive 
impacts  on 
human health in the EU and 
in 
third  countries  where 
WEEE is processed. 

Achieved,  not  quantifiable. 
Non-compliant products can 
reduce the positive effect. 

Achieved to some extent.  

On the benefits related to innovation, for instance, most stakeholders acknowledged that 
the  Directive  has  made  a  positive  contribution  to  innovation  as  it  has  stimulated 
substitution  to  use  EEE  that  contain  less  harmful  substances  (see  Figure  5).  One  such 
example is related to innovation in the lighting industry. Following the entry into force of 
time-limited  exemptions  for  the  use  of  mercury  in  certain  lamp  categories,  there  have 
been  new  investments  and  software  innovation  in  mercury-free  LED  technology88. 
However,  certain  stakeholders  representing  categories  8  and  9  of  Annex  I  to  the 
Directive89 reported negative impacts  on innovation as  the need to  allocate  resources to 
find alternatives to RoHS substances in their products reduced the resources available to 
conduct research and development. 

88   The  RoHS 1  Directive  entered  into  force  in  2003.  At  a  later  stage,  the  ecodesign  requirements  for 

lamps under Commission Regulation (EC) No 244/2009 supported further innovation. 

89   Category  8:  Medical  devices,  category  9.  Monitoring  and  control  instruments  including  industrial 

monitoring and control instruments. 

32 

 
 
 
 
 
 
 
Figure 5: Expert OPC responses: Effect on innovation (N=101) 

In regulatory terms, the above benefits can be categorised in benefits related to improved 
wellbeing  (health  and  environmental  benefits)  and  market  efficiency  benefits  (benefits 
related to improving the internal market and boosting innovation), as shown in Figure 6. 
In  addition,  the  global  impact  of  the  EU’s  RoHS  Directive  is  a  regulatory  benefit  that 
exceeds the benefit to the internal market (see point 4.2.1). 

Figure 6: Overview of the regulatory benefits of the RoHS Directive (Source: evaluation study) 

The regulatory costs can be broken down into three categories, information compliance 
costs, engineering compliance costs, and enforcement & implementation costs. 

Information compliance costs 

33 

Regulatory benefitsImproved wellbeingMarket efficiencyHealth benefitsReduction in the hazardous substances exposure for workers in production and  WEEE recycling plantsDecreased negative health effects to consumers Environmental benefits Avoided emissions of hazardous substances Decrease of hazardous substances in WEEE and improved recyclability of EEEContribution to circular economyEconomic benefitsContribution to proper functioning of internal marketIncrease in innovation 
 
 
 
 
 
 
The compliance costs for businesses related to the RoHS Directive include collecting and 
reviewing information, gathering supply chain information, costs related to dedicated IT 
systems to manage all required information, and costs related to the exemption system. 

The Directive sets out the specific obligations of manufacturers in Article 7, of importers 
in  Article 9,  and  of  distributors  in  Article 10.  When  placing  EEE  on  the  market,  the 
manufacturer must ensure that they have been designed and manufactured in accordance 
with  the  substance  restrictions.  This  includes  the  conformity  assessment  procedure, 
carried out here as internal production control, which includes technical documentation, 
quality  management  in  manufacturing,  affixing  the  CE  marking  and  issuing  the  EU 
declaration of conformity. Importers and distributors must ensure that the manufacturer 
has  fulfilled  their  obligations.  All  economic  actors  must  make  available  the  requisite 
information (e.g. the serial number of the EEE or the contact point) and must ensure that 
further information can be made available to competent authorities upon request. 

In addition to the costs for manufacturers, there are also costs for raw material suppliers 
as they have to provide information to the manufacture as input to create the mandatory 
technical documentation. The information must be managed and provided throughout the 
whole supply chain, which creates costs for these companies. 

However, it is not possible to quantify the costs of compliance with the RoHS Directive. 
Companies  bundle  tasks  related  to  general  compliance  or  administration,  and  do  not 
typically have one team specifically in charge of RoHS compliance but teams responsible 
for compliance with a long list of pieces of legislation. The staffing costs in FTEs related 
to the RoHS Directive depend on many factors,  such as the size of the company or the 
EEE categories  produced. For many businesses (N=11) that report  having  fewer than 3 
FTEs, the average is 0.28 FTE per year; larger companies may have more. 

Most compliance  costs stem  from  the  general requirements for placing products  on the 
market (e.g. providing technical documentation). Some costs are fixed and stay the same, 
even for producers of equipment that fell in scope when the Directive was extended. 

Companies  (in  particular  EEE  manufacturer)  that  still  require  time-limited  exemptions 
also  face  another  form  of  compliance  costs.  Some  businesses  already  use  substituted 
hazardous substances in their products. Some do not have to apply for an exemption, as 
exemptions under the RoHS Directive are valid for all companies and thus the costs are 
carried by one company or one consortium (see more under point 4.1.6). The main costs 
are  linked  to  preparing  the  application  form  and  answering  questions  during  the 
evaluation process. 

Applying  for  an  exemption  under  the  RoHS  Directive  is  free  of  charge,  unlike  the 
authorisation process under REACH where fees are charged in line with the polluter-pays 
principle90. A fee for processing requests for exemptions was brought in in April 202391 
under the UK’s new RoHS legislation, which was based on the EU RoHS Directive. 

Engineering compliance costs 

90   Article 62(7) and Title IX of REACH. 
91 

https://www.gov.uk/government/consultations/fees-for-processing-applications-for-exemptions-from-

rohs-regulations (23-01-2023). 

34 

 
 
 
Manufacturers indicated that another major cost driver is the cost of technical compliance 
to  comply  with  the  hazardous  substance  restrictions  in  their  product  (in  the  product 
development  phase).  In the business  focus  group, participants  noted  this  includes R&D 
costs and the cost of validating alternatives. Those engineering costs mainly occurred in 
around 2002 when the RoHS Directive came into force and restricted the use of certain 
substances.  

There are national and European funds and programmes (e.g. InvestEU, Horizon Europe, 
LIFE)92  that  support  research  and  innovation  to  achieve  phasing-out  hazardous 
substances. 

Another increase  in costs is  expected when  the scope  extends from RoHS 1 to  RoHS 2 
and  the  four  phthalates  are  included  in  the  list  of  restricted  substances.  For  many 
companies, the cost of investing in finding alternatives fall over time as the EEE sector 
develops.  Once  alternatives  exist  and  are  available,  R&D  investments  are  no  longer 
needed to replace the hazardous substances. However, some companies may struggle to 
find reliable substitutes and others may have applications for which alternatives are not 
expected to be available in the near future. 

For EEE that remain excluded by time-limited exemptions, companies continue to spend 
on  R&D  to  seek  substitutes  or  to  redesign  their  products  with  different  ambitions.  The 
cost of applying for an exemption may be an incentive to seek opportunities to substitute 
hazardous  substances  in  products  rather  than  to  collect  and  submit  the  extensive  data 
required to make a substantiated application. 

Enforcement & implementation costs 

Based on the responses  received  from 10 Member States,  the range of FTEs  needed  to 
enforce and implement per Member State is between 0.3 to 4.75 FTE per year. The total 
budget including staffing costs ranges from EUR 10 000 to over EUR 400 000 per year. 
For most Member States, the enforcement costs are higher than the implementation costs. 
The enforcement of the substance restrictions appears to be the largest cost heading. 

The cost of transposing amendments via delegated directives into national legislation is 
the main cost involved in implementation. Out of the 15 responding Member States, 10 
indicated that they have to transpose these changes ‘manually’ in the national legislation 
and  five  said  that  they  have  ‘dynamic’  links  to  Annexes  III  and  IV  to  the  RoHS 
Directive,  which  means  they  have  cross-reference  to  the  European  legislation  without 
specifying the content. According to the Member States, ‘manual’ transposition requires 
between  two  and  12  months,  though  most  indicated  it  took  considerably  less  than  12 
months.  A  rough  estimate  of  the  cost  of  implementing  four  delegated  directives  is 
between EUR 9 178 and EUR 55 066 per year and per Member State. Assuming that 2/3 
of all Member States (18) lack ‘dynamic’ links, the yearly costs involved in transposing 
delegated acts is estimated at between EUR 165 000 and EUR 991 000. 

The  main  cost  for  the  European  Commission  is  in  running  the  exemption  system.  The 
European Commission spends on average the equivalent of 1.0 FTE per year on in-house 

92    https://investeu.europa.eu/index_en 

https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-
open-calls/horizon-2020_en 
https://cinea.ec.europa.eu/programmes/life_en 

35 

 
 
staffing  and  around  EUR 150 000  per  year  on  studies  to  amend  Annexes  III  and  IV93. 
Under Article 5(1)(a), it amends the Annexes by issuing specific delegated acts. Since the 
RoHS 2  Directive  entered  into  force  in  2011,  around  80  delegated  acts  were  adopted 
under the RoHS Directive (as at December 2022). Not all exemption requests resulted in 
a  delegated  directive.  Some  were  considered  unjustified  for  an  exemption,  some  were 
merged into  one act  and some were  withdrawn  by the applicant.  That  means that  there 
were more exemption requests submitted and evaluated than delegated acts adopted. 

The  number  of  exemption  requests  has  increased  over  the  years.  One  reason  is  that 
exemptions in several entries had to be more specific, which creates technical complexity 
and  requires  a  higher  level  of  detail  (see  also  Chapter  2.2.3).  The  other  reason  is  that 
different expiry dates for EEE categories related to one exemption entry increases further 
the number of entries. 

The  number  of  pages  for  exemptions  has  also  increased  over  the  years.  In  2003,  there 
was only one annex with one page. In 2011, two annexes were adopted and the number 
of  pages  increased  to  six.  In  2022,  the  list  of  exemptions  ran  to  18  pages,  with  some 
listed exemptions having already expired. 

The  number  of  exemption  requests  with  decisions  pending  has  accumulated  over  the 
years.  By  December  2022,  over  60  exemption  requests  were  pending,  most  being 
requests to renew existing exemptions. 

Figure 7 gives an overview of the regulatory costs associated with the RoHS Directive. 

Figure 7: Overview of regulatory costs for the RoHS Directive (Source: evaluation study) 

Conclusions 

Although the costs and  benefits cannot be quantified in monetary terms, the benefits in 
terms of improved wellbeing or market efficiencies can be assumed to be of higher value 
than the compliance and implementation costs. The costs for industry in complying with 
the  RoHS  Directive  are  expected  to  be  partly  offset  by  the  economic  benefits.  This 
applies especially  to  the costs spread over more  than 20 years  in  which  a directive has 

93   Average  costs  for  the  years  2017-2022;  the  costs  for  external  contracts  fluctuate  significantly  over 

years depending on the number of requests. 

36 

 
 
 
 
been in place. Prioritising a healthy environment and good public health plays a key role 
in  achieving  a  more  sustainable  industry.  According  to  the  Evaluation  Study, 
stakeholders  also  generally  agreed  that  the  costs  of  the  Directive  were  justified. 
Annex IV gives an overview of the estimated costs and benefits of the Directive. 

4.1.6  The exemption process is not sufficiently transparent and efficient 

The evaluation process concluded that certain provisions on exemptions to the Directive 
(Article 5, Annexes III and IV) lack transparency, efficiency and internal coherence. 

On the issue of internal coherence, some stakeholders stated that they have found gaps, 
contradictions, overlaps or missing links within the Directive. On closer examination of 
these  statements,  it  appears  that  it  is  rather  a  question  of  understanding  and  unclear 
wording,  which  leads  to  different  interpretations  by  stakeholders.  Some  of  the  issues 
raised do not concern the exemption process and they are tackled in point 4.1.9. 

Many  stakeholders  identified  the  exemption  procedure  as  an  area  in  need  of 
improvement. They highlighted the need to: 

▪ 
▪ 
▪ 

improve the transparency and predictability of the exemption process; 
reduce the length of the process to evaluate and grant exemptions; 
increase the validity period of exemptions and the length of transition periods. 

Exemption process 

By  running  targeted  surveys  and  interviews,  the  evaluation  study  ascertained  that  the 
Directive’s  main  issue  of  transparency  and  predictability  concerns  the  lack  of  clarity 
and/or guidance on the methodologies to use for the exemption procedure. 

The  Commission’s  RoHS  website  (section  ‘Implementation’)94  provides  information 
about the procedure and the timeframe of the exemption process.  It includes a guidance 
document published in 2012 and the application form to request an exemption to guide 
stakeholders on the process and in planning any exemption request. 

Since  2011,  all  applications  for  an  exemption  must  contain  the  elements  described  in 
Annex  V.  However,  the  evaluation  found  that  many  applications  contained  only 
superficial or outdated information on these points (for example, life cycle assessments 
not in line with official standards), indicating the need to clarify and update these points. 

The  Commission  published  an  exemption  evaluation  methodology  based  on 
Article 5(1)(a) of the RoHS Directive in November 202095. However, to date, no official 
EU  guidance  documents  have  been  adopted  to  explain  the  methodology  to  use  when 
making Article 5(1)(a) applications. 

It could not be confirmed that obliging economic operators to justify their request for an 
exemption in a regular term encourages the substitution of hazardous substances in EEE 
(see 4.1.1).  

https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/implementation-rohs-

94 
directive_en 
95   Study  underpinning  the  review  of  the  list  of  restricted  substances  and  to  assess  a  new  exemption 
–  Chapter  A.10.0  Exemption  Methodology 

request 
https://op.europa.eu/o/opportal-service/download-handler?identifier=ce50dc9c-6c19-11eb-aeb5-
01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=. 

under  RoHS 

(Pack 

15) 

2 

37 

 
 
This assessment also found that some applications repeated the same arguments and time 
periods  needed  to  make  the  substitution  as  used  in  previous  applications,  even  many 
years  later.  This  can  significantly  hamper  substitution  and  undermine  other  efforts  to 
substitute  hazardous  substances.  With  regular  reviews,  it  is  important  not  to  start  from 
the beginning and not to re-evaluate the same arguments made in previous applications. 

In line with the Better Regulation guidelines, and in addition to the consultation phase in 
the  technical  exemption  assessment,  the  Commission  publishes  the  draft  delegated  acts 
for feedback for four weeks on the Have Your Say website96. 

In addition to the need to improve the transparency of the exemption process itself, three 
stakeholders mentioned that it is difficult to track changes to exempt applications and 
the  publication  of  new,  reformulated,  and  deleted  exemptions.  To  date,  the  current 
and consolidated version of the RoHS Directive including the annexes is available online 
via  EurLex  and  on  the  Commission’s  RoHS  website.  The  European  Commission  also 
publishes frequent  updates to  the list  of RoHS  exemptions  with  the validity period and 
the  related  rolling  plan97.  While  this  list  does  not  have  any  legal  status,  it  assists 
stakeholders in  tracking  exemption  changes  and  the validity of  exemptions  for which  a 
renewal  has  been  requested.  Stakeholders  can  also  subscribe  to  platforms98  run  by  the 
consultants assisting the Commission with exemption evaluations, which publish regular 
updates on new studies and consultations. These platforms are project-related and depend 
on the consultants commissioned. 

Criteria for exemptions 

Stakeholders  felt  that  Article 5(1)(a),  which  lays  down  provisions  on  the  criteria  for 
granting, renewing or revoking exemptions, lacked clarity. 

One  example  provided  by  a  Member  State  competent  authority  was  whether  a  socio-
economic  assessment  is  a  ‘set’  part  of  the  methodology  to  be  applied  under 
Article 5(1)(a) of the RoHS Directive. On this point, one business association stated that 
according to the current interpretation of the RoHS Directive, it is not possible to grant 
an  exemption  based  on  additional  factors  mentioned  in  Article 5(1),  such  as  the 
availability of substitutes and the results of a socioeconomic assessment; these elements 
should become set criteria under the Article 5(1) RoHS methodology. Another business 
association  indicated  the  need  for  a  clear  socioeconomic  assessment  under  Article 5(1) 
and suggested seeking the expertise of the Risk  Assessment  Committee (RAC) and the 
Socio-Economic  Analysis  Committee  (SEAC)  under  the  REACH  Regulation  in  the 
RoHS socio-economic assessment. 

On the third criterion99 in Article 5(1)(a), stakeholders indicated the need for the process 
and  methodology  for  the  decision  on  exemption  applications  to  clearly  set  out  how  to 
quantify  and  evaluate  the  ‘total  environmental  and  human  health  benefits  of  an 
innovative  new  technology’.  Clear  guidance  on  how  to  quantify  and  evaluate  the  total 

96   https://ec.europa.eu/info/law/better-regulation/have-your-say_en 
97 
of 

Implementation 
https://ec.europa.eu/environment/topics/waste-and-recycling/rohs-directive/implementation-rohs-
directive_en. 

Commission, 

European 

RoHS 

the 

Directive, 

98   The  Oeko-Institut  ‘RoHS  evaluations’  platform  enables  stakeholders  to  register  for  notifications  on 

studies and consultations, see: https://rohs.exemptions.oeko.info/registration. 

99   The total negative environmental, health and consumer safety impacts caused by substitution are likely 

to outweigh the total environmental, health and consumer safety benefits thereof. 

38 

 
 
environmental and human health benefits would reduce the costs to industry in drafting 
exemption applications. 

 The  Commission  published  a  guidance  document  for  RoHS  exemption  requests  on  its 
website100,  where  the  criteria  are  further  interpreted.  However,  it  seems  that  for 
stakeholders not all questions are answered. 

Duration of process 

Several  stakeholders  pointed  out  that  the  time  required  to  evaluate  and  grant  an 
exemption  has  increased  from  12-18  months  in  2006  to  3  years  or  more  in  2020  (they 
indicated up to 40 months). The average time it takes to evaluate exemptions and run the 
decision process to amend the annexes is over 24 months (status December 2022). 

The  stakeholders  who  raised  this  point  explained  that,  in  their  view,  excessively  long 
timeframes  for  evaluation  puts  significant  legal  and  planning  uncertainty  on  European 
companies, and this has an impact on their competitiveness. 

The timeframe for making an exemption decision depends on several factors. One factor 
is that changes on exemptions must be integrated in the annexes by adopting individual 
delegated  directives.  This  means  that  every  change  to  an  exemption  requires  a  full 
decision-making  process 
to  adopt  a  delegated  directive.  These  administrative 
requirements can multiply the workload and increase the length of the process. 

Another  factor  is  related  to  the  resources  available  for  the  exemption  process.  For  the 
Commission, resources are needed to manage and evaluate exemptions and manage the 
process of preparing, consulting on and adopting the delegated act. For the applicant, it is 
crucial to have sufficient resources to put together a quality application and communicate 
during the clarification and consultation phase. Especially where specialised technologies 
are covered by an exemption, the contributions made by other stakeholders (e.g. users of 
alternative  technology)  are  essential  to  verify  claims  in  the  application.  If  sufficient 
resources  are  not  available,  the  process  can  take  longer  as  it  is  harder  to  obtain  the 
information needed to make a balanced assessment. In fact, the trend observed in recent 
studies  (e.g.  under  Pack  26101)  is  that  fewer  stakeholders  are  now  contributing  to 
exemption evaluations, which could be related to a high workload. 

Another  issue  is  linked  to  the  fact  that  different  categories  and  maximum  exemption 
durations  are  specified  for  exemptions  from  different  EEE  categories.  This  results  in 
different  expiry  dates  for  the  same  material  or  technical  application102,  which  require 
individual  applications  and  evaluations  (increasing  the  administrative  costs).  This 
approach  results  in  more  entries,  making  the  exemptions  more  complicated  and  less 
comprehensible for stakeholders and enforcement authorities alike. Lastly, this approach 

100 

https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/implementation-rohs-

directive_en  

101   Study to assess request for one (-1-) exemption, for lead as a thermal stabilizer in polyvinyl chloride 
(PVC)  used  as  base  material  in  amperometric,  potentiometric  and  conductometric  electrochemical 
sensors which are used in in-vitro diagnostic medical devices for the analysis of creatinine and blood 
urea nitrogen (BUN) in whole blood, in Annex IV of Directive 2011/65/EU (Pack 26) 

102   For example, lead in copper alloy covered by exemption 6(c) in Annex III has three different expiry 

dates. 

39 

 
 
ties  up  more  resources  on  each  side,  with  limited  effectiveness,  and  it  can  delay  other 
decision-making processes. 

Validity and transition periods 

Under Article 5(2) of the RoHS Directive, exemption entries  are valid for up to five or 
seven years, depending  on their EEE category listed in  Annex  I.  For  example, medical 
devices (category 8), which often take a long time to develop, test and validate and have 
a longer lifetime than other EEE, may  be  valid  for up to  seven years. Applicants  often 
request exemptions for a maximum validity period, but do not always substantiate their 
request. 

that 

indicated 

longer  validity  periods 

Stakeholders 
for 
substances/products  when  substitutes  will  be  available  in  the  short-term.  Although 
categories 8 and 9 already have longer validity periods of up to seven years, the industry 
is in favour of longer validity periods due to the elaborate process of product checks and 
validations before these products can be approved for the market. 

should  be  granted 

Under Article 5(6) of the RoHS Directive, if an application for renewal is rejected or an 
exemption is revoked, the transition period must be set at between 12 and 18 months. In 
past  technical  assessments  of  exemption  requests,  some  technical  applications  were 
found to no longer require an exemption, but a transition period of 12 months still had to 
be  included  in  the  decision.  However,  other  technical  assessments  found  that  for 
technical  applications  that  no  longer  meet  the  criteria  in  Article 5(1)(a),  a  transition 
period  of  18  months  would  still  have  considerable  socio-economic  impacts  as  it  takes 
longer  than  this  to  adapt  complex  supply  chains.  Also,  where  it  is  foreseeable  that  the 
exemption  criteria  will  no  longer  be  met  at  a  specific  date,  beyond  18  months,  the 
Commission  must  grant  the  exemption  and  enable  stakeholders  to  re-apply  for  the 
exemption.  The  new  application  must  be  evaluated  again,  which  takes  on  average  12 
months. These limitations can lead to more administrative work, longer validity periods 
than justified and reduces the predictability of decisions on exemptions for stakeholders. 

4.1.7  The substance restriction process is not sufficiently transparent and efficient 

The  evaluation  process  indicated  that  the  process  to  review  and  amend  the  list  of 
restricted  substances  in  Annex  II  is  not  sufficiently  transparent  or  predictable  for 
stakeholders. 

Article 6, which lays down provisions  for reviewing and amending the list of restricted 
substances, contains the procedural requirement that any amendments of Annex II should 
be  periodically  assessed,  either  by  the  Commission  at  its  own  initiative  or  following  a 
proposal  submitted  by  a  Member  State.  The  Commission  must  also  consult  interested 
parties,  including  economic  operators,  recyclers,  treatment  operators,  environmental 
organisations and employee and consumer associations. 

Although  no official  guidance has been adopted, a practical  guidance  for the  substance 
restriction  methodology  based  on  RoHS  Article 6  was  prepared  for  the  Commission  as 
part of a study. This guidance was published in February 2021103. 

103   Study  underpinning  the  review  of  the  list  of  restricted  substances  and  assessing  a  new  exemption 
request under RoHS 2 (Pack 15)  – Chapter A.1.0 Methodology for Identification and Assessment of 
list  of  restricted  substances  https://op.europa.eu/o/opportal-
Substances  for  Inclusion 

the 

in 

40 

 
 
 
The  last  review  of  new  substances  covered  by  Annex  II  was  initiated  in  2015  and  a 
technical report published in February 2021. Seven substances or substance groups were 
evaluated, with no delegated act yet adopted based on Article 6(3). An informal working 
group  including  private-sector  stakeholders  was  created  to  facilitate  information 
exchange  between  stakeholders  and  the  Commission104.  The  process  included  four 
consultation  rounds  with  stakeholders  and  three  stakeholder  meetings.  As  for  the 
preparation of all delegated acts, the Member States expert group was also consulted105. 

Several industry stakeholders are of the opinion that the methodology for reviewing the 
list of restricted substances under Article 6 should adopt elements of the methodology for 
identifying  and  restricting  substances  under  the  REACH  Regulation,  such  as  the 
socioeconomic assessment. It should also take account of the expertise of the SEAC and 
RAC. In line with the ‘one substance, one assessment’ principle in the framework of the 
chemicals  strategy  for  sustainability,  the  Commission  sees  potential  to  create  synergies 
with  existing  procedures  regulating  hazardous  substances  and  to  improve  coherence 
between different pieces of legislation. 

4.1.8  Lack of clarity and adaptation provisions to reflect latest developments 

Stakeholders in the evaluation process often mentioned the need to clarify the terms and 
procedures  and  to  issue  more  guidance  documents.  This  includes  updating  existing 
guidance  documents,  since  the  current  ‘Frequently  Asked  Questions’  document  was 
produced in 2012106. 

Examples  include  the  question  as  to  whether  lamps  come  under  category  5  ‘lighting 
equipment’ or under the EEE category of the final product, and questions on the scope of 
the  Directive.  Stakeholders  had  many  questions  regarding  the  meaning  of  ‘large-scale 
applications’ within the scope exclusions in Article 2(4), with some aspects explained in 
the FAQ document. 

Some  stakeholders  asked  for  clarification  of  radio  frequency  identification  (RFID) 
applications.  RFID  is  typically  described  as  a  small  chip  (or  tag),  which  can  store 
information  digitally  and  be  attached  to  a  wide  range  of  products.  The  Commission 
answered the question regarding scope, whether the RoHS requirements should apply to 
the RFID only or also to related article, in the current set of FAQ. Stakeholders may still 
require further clarification as the market for RFID tags has expanded in recent years. 

Currently,  Article 2(4)(i)  of  the  RoHS  Directive  specifies  that  the  Directive  must  not 
apply  to  photovoltaic  panels  (PVP)  intended  to  be  used  in  a  system  that  is  designed, 
assembled  and  installed  by  professionals  for  permanent  use  at  a  specified  location  to 
produce solar energy for public, commercial, industrial and residential applications. This 
exclusion does not apply to incorporated parts, e.g. pocket calculators, and it should help 
achieve the aim to increase the share of renewable energy in energy production. 

However,  there  are  some  arguments  in  favour  of  reviewing  this  scope  exclusion.  First, 
the installation of PVP has continued to rise strongly. Second, the vast majority of PVP 

service/download-handler?identifier=ce50dc9c-6c19-11eb-aeb5-
01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=. 

Expert group E03063 

https://intragate.ec.europa.eu/regexpback/screen/expert-

groups/details?groupId=3063. 

Expert group E02810 

https://intragate.ec.europa.eu/regexpback/screen/expert-

104 

105 

groups/details?groupId=2810. 

106   https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive_en  

41 

 
 
technologies  currently  installed  (Crystalline  silicon,  cadmium  telluride  and  perovskite) 
are reliant on applications that require the use of lead and/or cadmium in concentrations 
higher than the limits set in Annex II to the RoHS Directive. 

The  waste  management  of  these  PVP  is  becoming  an  increasingly  pressing  concern. 
PVPs have been included in the scope of the WEEE Directive since 2012 and are subject 
to  its  requirements.  This  includes  the  provisions  on  separate  collection,  extended 
producer responsibility and treatment. 

The  challenge  for  this  exclusion  is  to  protect  human  health  and  the  environment  from 
hazardous  substances  that  modern  PVP  contain,  while  not  significantly  restricting  the 
installation and development of new solar cells in Europe and enabling a fast transition to 
a fossil fuel free energy sector. 

4.1.9  Lack  of  coherence  (consistency)  with  other  related  pieces  of  legislation  and 

policy goals 

EU  legislation  does  not  function  in  isolation.  It  interacts  with  other  areas  of  EU  action 
and the RoHS  Directive is  no  exception.  The  RoHS  Directive  makes explicit links and 
references  to  other  pieces  of  legislation  and  vice  versa,  and  the  practical  effects  of  the 
Directive influence the functioning or effectiveness of other legislation, and vice versa. 

86% of respondents (N=74) under the OPC indicated that there was an issue of ‘external 
coherence’, i.e. coherence (consistency) between the RoHS and related legislation. 8 out 
of  15  respondent  Member  States  also  indicated  an  issue  of  external  coherence.  The 
regulatory  mapping  and  subsequent  consultation  activities  carried  out  as  part  of  the 
evaluation study found that at least 15 EU legislative measures are directly related to the 
RoHS Directive107. 

The main issue of the RoHS Directive’s external coherence was found to be the overlap 
between the substance restrictions laid down in the RoHS and the substance restrictions 
laid  down  in  Regulation  (EC)  No 1907/2006  (‘REACH  Regulation’),  by  Directive 
2009/125/EC  (‘Ecodesign  Directive’)  and  Regulation  (EU)  2019/1021  (‘POPs 
Regulation’). 

The above-mentioned pieces of legislation contain mechanisms to restrict the presence of 
certain  substances  that  could  also  affect  EEE.  The  mechanisms  can  differ,  which 
complicates  the  issue,  and  can  create  confusion  for  stakeholders.  The  Commission  is 
coordinating  these  different  mechanisms  and  their  outcome  to  improve  external 
coherence between those pieces of legislation. For example, the Commission published a 
common  understanding  paper  in  2014  on  managing  regulatory  action  on  the  same 
chemical substances under REACH and the RoHS Directive108. 

The  maximum  concentrations  of  substances  to  be  tolerated  in  EEE  have  not  been 
changed  since  they  were  introduced  in  the  RoHS  Directive.  However,  technical  and 
scientific progress has resulted in changes in the concentration limits for some of these 
substances in other chemicals legislation such as REACH or POPs. 

For example, Annex I to the POPs Regulation restricts, among others, the placing on the 
market  of  articles  containing  more  than  500 mg/kg  PBDE.  However,  EEE  under  the 

107   See Appendix IV to the evaluation study available at https://data.europa.eu/doi/10.2779/89335. 
108   European  Commission,  REACH  and  Directive  2011/65/EU  (RoHS)  a  common  understanding  Ref. 

Ares(2014)2334574 14/07/2014. 

42 

 
 
scope  of  the  RoHS  Directive  is  excluded  from  this  restriction.  The  RoHS  Directive 
allows up to 1000 mg/kg PBDE in homogenous material in EEE. However, PBDE is no 
longer intentionally added to EEE material above 500 mg/kg, which is suggested by the 
fact that no RoHS exemption covers new EEE applications. The main use of PBDE as a 
flame retardant requires considerably more than 1000 mg/kg. 

It could be argued that PBDE in EEE coming from recycled WEEE streams and residual 
concentrations between 500-1000 mg/kg may still be relevant for EEE. However, under 
the POP Regulation it was shown that maximum concentration levels of PBDE in waste 
can be lowered to 500 mg/kg and, under certain conditions, even lower in future109. That 
means  there  might  be  no  longer  a  need  for  the  concentration  range  between  the  POP 
concentration level of 500 mg/kg and the RoHS concentration level of 1000 mg/kg.  

Reducing the concentration limits set in Annex II to the RoHS Directive would be in line 
with  the  EU  chemicals  strategy  for  sustainability  towards  a  toxic-free  environment. 
Doing so would also increase coherence between both pieces of legislation. 

restricts 

There are other aspects of inconsistency between legislation too. For example, the POPs 
Regulation 
the  substance  hexabromobiphenyl  without  any  maximum 
concentration  level.  This  substance  is  part  of  the  group  of  polybrominated  biphenyls 
(PBB),  which  is  restricted  by  the  RoHS  Directive,  which  sets  a  maximum  limit  of 
1000 mg/kg in homogenous material. 

On the links between RoHS and REACH, REACH established mechanisms that restrict 
the use and placing on the market of specified substances in articles, including EEE. The 
most  relevant  mechanisms  to  this  end  are  ‘restrictions’  (Title  VIII,  Annex  XVII)  and 
‘authorisations’  (Title  VII,  Annex  XIV).  Some  entries  under  Annex  XVII  of  REACH 
contain exemptions for articles in the scope of the RoHS Directive, such as the entries for 
lead110, OctaBDE111 and DecaBDE112 and the listed phthalates113. Currently, RoHS and 
REACH both contain provisions regulating the use of substances listed in Table 3. 

Table 3: Overview of substances covered both by REACH and RoHS (Source: evaluation study) 

Substance 
Lead 

Mercury 

Cadmium 
Hexavalent chromium 

PBB 
PBDE 

REACH 

Entry 63 under Annex XVII 
Entries 10, 11 and 12 under Annex XIV (Lead compounds) 
Entries 18 and 18a under Annex XVII 

Entry 23 under Annex XVII 
Entry 47 under Annex XVII 
Entries  16-22  and  28-31  under  Annex  XIV  (Chromium-(VI) 
compounds) 
Entry 8 under Annex XVII 
Entry 67 under Annex XVII (DecaBDE)114 
Entry 45 under Annex XVII (OctaBDE) 

109   OJ  L  317,  9.12.2022,  p. 24-31  -  Regulation  (EU)  2022/2400  amending  Annexes  IV  and  V  to  POPs 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R2400. 

110   Annex XVII REACH, entry 63, par. 8, sub k. 
111   Annex XVII of REACH entry 45 paragraph 3. 
112   Annex XVII REACH, entry 67, par 4 sub d. 
113   Annex XVII REACH, entry 51, par 4 sub h. 
114   This entry is expected to be removed after the listing of DecaBDE under Annex I to Regulation (EU) 2019/1021 

(POPs Regulation). 

43 

 
 
REACH 

Entry 4 under Annex XIV and Entry 51 under Annex XVII 
Entry 5 under Annex XIV and Entry 51 under Annex XVII 
Entry 6 under Annex XIV and Entry 51 under Annex XVII 
Entry 7 under Annex XIV and Entry 51 under Annex XVII 
Entry 72 under Annex XVII 

Substance 
DEHP 
BBP 
DBP 
DIBP 
Substances  listed  in  Appendix  12 
to REACH: 
Cadmium and its compounds 
Chromium-(VI) compounds 
Lead and its compounds 

Therefore, the main issue raised by stakeholders regarding coherence between the RoHS 
Directive  and  the  REACH  Regulation  concerns  the  perception  that  these  two  pieces  of 
legislation amount to double regulation of substances in EEE115. A considerable number 
of  stakeholders  (n=66/N=101),  mainly  businesses  but  also  some  Member  States, 
indicated  that  restricting  the  same  substances  under  both  the  RoHS  and  REACH 
directives creates legal uncertainty. Stakeholders indicated that restrictions of a substance 
under RoHS and REACH may differ in terms of: 

▪  maximum concentration values; 
▪  scope of the legislation; 
▪  exemptions and their expiry dates; 
▪  differences in spare parts; 
▪  product information requirements; and 
▪  documentation requirements. 

Industry stakeholders provided the following specific examples of perceived incoherence 
under the OPC of the evaluation: 

▪  Entry 72 of Annex XVII references Appendix 12, which includes concentration levels 
in  restrictions  of  cadmium,  hexavalent  chromium  and  lead  that  are  lower  than  the 
levels  set  under  the  RoHS.  Certain  textile  items  such  as  fabric  straps  for  electronic 
fitness monitors, watches and similar devices are covered by both REACH and RoHS. 
Some stakeholders stated that this creates an unintentional  overlap and  contradiction 
in the requirements. However, it is unclear how the different maximum concentration 
values correspond to each other and to what extent this affects other stakeholders. 
▪  Entry  51  ‘phthalates’  of  Annex  XVII  states  that  EEE  is  excluded  from  the  scope  of 
RoHS but spare parts, components and supplied parts might not be EEE and thus they 
are  restricted  under  REACH  to  a  maximum  concentration  of  0.1%  by  weight  of  the 
plasticised material in the article. However, spare parts are not covered by the RoHS 
restrictions and excluded under Article 4(4) and 4(5). The relevance of this problem is 
unclear though. 

Stakeholders indicated that these differences may give rise to legal uncertainty. This may 
also  result  in  problems  in  enforcing  the  provisions.  However,  it  seems  that  these 

115   An ‘article’ is defined under REACH as an object which during production is given a special shape, surface or 
design which determines its function to a greater degree than does its chemical composition. This definition also 
covers EEE. 

44 

 
 
 
inconsistencies only apply to some stakeholders, and that to resolve the issue it would be 
sufficient to issue a clarification. 

As  for  the  potential  overlap  between  the  RoHS  and  the  Ecodesign  Directive,  close  to 
40%  of  OPC  respondents  (n=86/N=101)  indicated  that  there  are  unnecessary  overlaps, 
gaps  and  contradictions  between  the  RoHS  and  the  Ecodesign  Directive.  4  of  the  15 
respondent Member States116 made the same observation. 

Despite the relatively high percentage of stakeholders mentioning coherence issues, only 
a few provided specific examples. A reason for the high share of questions on coherence 
might be the increasing electrification of many devices (e.g. internet of things). 

In addition, a number of stakeholders under the OPC highlighted the connection and need 
for  future  coherence  between  the  RoHS  and  the  EU's  circular  economy  policy,  in 
particular with the 2020 circular economy action plan (CEAP) and the chemicals strategy 
for  sustainability.  The  RoHS  has  considerable  links  to  EU  policy  on  the  circular 
economy, as it facilitates sound and safe WEEE treatment and recycling and reduces the 
scope to keep circulating hazardous substances in products. Exemptions under the RoHS 
Directive  enable  the  use  of  certain  spare  parts  and  the  reuse  of  certain  recovered  spare 
parts containing restricted substances to facilitate the repair of EEE. 

In  relation  to  coherence  to  other  related  initiatives,  terms  such  as  ‘closed-loop  return 
systems’  used  in  the  Directive  should  be  aligned  with  other  CEAP  initiatives.  Another 
example would be suggestion to flag the presence of hazardous substances in EEE due to 
an exemption in a future digital product passport. 

4.2  How did the RoHS Directive make a difference? 

Overall response: 

The RoHS Directive yields benefits for environmental protection, human health and for 
the  internal  market.  While  similar  levels  of  environmental  and  health  protection  could 
well have been achieved at national level, the full added value of the RoHS Directive is in 
facilitating the internal market. 

Harmonising  rules  to  ease  the  free  exchange  of  goods  across  the  EU  were  cited  as  a 
reason for proposing legislation on this subject in 2000, since several Member States had 
adopted or developed legislation on hazardous substances in electronics. The same level 
of  harmonisation  could  not  have  been  achieved  without  the  RoHS  Directive.  The 
Directive also provides clear EU added value in its influence on third countries, , which 
would not have happened without harmonisation at EU level. 

This  section  evaluates  the  EU  added  value  of  the  Directive  by  exploring  whether  the 
objectives  could  have  ‘been  better  achieved  at  EU  level’  than  could  be  reasonably 
expected  by  taking  action  at  national  level.  The  key  points  to  assess  are  whether  the 
Directive  produced  results  beyond  what  would  have  been  achieved  by  Member  States 
acting alone and the Directive’s added value for individuals and businesses in the EU. 

116   Norway also indicated unnecessary overlaps, gaps and contradictions exist between the RoHS and the Ecodesign 

Directive. 

45 

 
 
 
The key aspect where the RoHS Directive has made a difference, compared to similar 
action taken at Member State level, is in facilitating the internal market. 

In  particular,  since  it  entered  into  force,  the  RoHS  Directive  has  improved  the 
consistency  of  national  conditions  and  resolved  the  fragmentation  in  the  regulation  of 
hazardous substance  restrictions  regarding EEE in the  EU. National  legislation on EEE 
and WEEE was in place or in preparation when the RoHS Directive was implemented in 
the early 2000s. Legislation governing WEEE was either planned or already in place in 
more than half of the  EU's  15 Member States  and for six  out of 15 Member States  for 
hazardous substances in EEE, including lead and cadmium117. 

In the absence of a harmonised regulation at EU level, this legislation would have most 
likely  remained in  place and potentially  even more countries could  have passed  similar 
legislation. One can assume that national-level legislation would have contributed to the 
protection of human health and the environment by setting national standards. However, 
the examples cited above neither covered the same products or substances as the RoHS 
Directive, nor did they set equal standards. Therefore, national legislation would have led 
to  varying levels  of protection. Given the constraints in  resources in  other EU Member 
States, it is reasonable to assume that some countries would not have adopted or enforced 
RoHS-like  legislation  fully.  This  in  turn  could  have  had  negative  effects  on  protection 
levels. Setting EU-wide standards as the RoHS Directive does solves this issue. 

The  inconsistency  of  national  legislation  in  terms  of  scope  (both  products  and 
substances)  and  limits  highlights  that  the  added  value  of  the  RoHS  Directive  is  more 
clear  cut  in  facilitating  the  internal  market.  With  regards  to  the  internal  market,  the 
proposal for RoHS legislation noted that  ‘diverging requirements on the phasing-out of 
specific  substances  could  have  implications  on  trade  in  electrical  and  electronic 
equipment.’118 As the distribution of EEE does not happen in one state, it can be assumed 
that,  without  harmonised  provisions,  companies  would  face  immensely  higher  costs  to 
comply with all national laws. 

The EU RoHS  Directive contributed to the functioning  of the internal  market as  it sets 
harmonised  substance  restrictions  standards  across  countries.  It  was  assessed  as 
overwhelmingly positive in providing EU added value, in particular: 

• 
• 
• 

the RoHS Directive creates a large market for the same EEE; 
the RoHS Directive simplifies the trade of EEE in the EU; 
the RoHS Directive supports innovation and the use of hazardous substance-free 
products. 

4.2.1  The RoHS Directive has a global impact 

The RoHS Directive influenced considerably the development of regulatory frameworks 
regarding  hazardous  substances  in  EEE  in  third  countries.  Several  stakeholders  and 
business associations consulted for the study have confirmed that this is still valid. 

According  to  literature  and  statements  by  business  associations,  the  2002  adoption  of 
RoHS has ‘led to a global change in the design of electronic products, as multinational 

117 Austria, Germany, Finland, Denmark, Sweden and the Netherlands. 

118   Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  on  the  restriction  of  the  use  of  certain 

hazardous substances in electrical and electronic equipment, COM/2000/347/Final. 

46 

 
 
companies who sell into the EU’s market often opted to use the EU’s stringent standards 
across their global production to save production costs’119. The first harmonised standard 
under RoHS became the basis for the international standard. With the current European 
harmonised  standard  EN  IEC  63000:2018  governing  technical  documentation,  the  new 
standard removed some specific wording used in the previous EU RoHS Directive. 

Figure 8: RoHS Directive and RoHS-like legislation in the world (Source: evaluation study)120 

A  considerable  number  of  non-EU  countries121  have  adopted  legislation  that  is  highly 
similar to  RoHS.  These  are shown in  green in  Figure  8.  The number of third countries 
with RoHS-like legislation is likely to increase in the near future, as draft legislation is 
being  discussed  in  more  jurisdictions,  including  the  Gulf  Cooperation  Council  member 
countries122, Brazil and Argentina. These countries are highlighted in yellow in the map. 

Although  the  RoHS  Directive  does  not  restrict  the  export  of  EEE,  it  is  assumed  that 
exports of WEEE placed on the European market, or new EEE with a reduced volume of 
hazardous substances due to the substance restrictions under RoHS has a major impact. 
In 2019, the EU Member States exported 119 279 tonnes of WEEE containing hazardous 
substances  and  14 557  tonnes  of  non-hazardous  WEEE.  Since  secondary  (treated) 
material  streams  such as  non-ferrous  metals  make  up almost  1.9 m tonnes  of exports123, 
and illegally exported waste is not included in these figures, the impact goes beyond the 
WEEE material stream. 

4.3 

Is the RoHS Directive still relevant? 

Overall response: 

119   The Brussels effect: how the European Union rules the world, Anu Bradford, 2020. 
120   Illustration based on The Brussels Effect, Anu Bradford, 2020. 
121   According  to  DigitalEurope  and  JBCE,  RoHS  was  taken  up  in  about  40  jurisdictions  outside  the  EU, 
https://www.digitaleurope.org/wp/wp-content/uploads/2020/06/DIGITALEUROPE-initial-views-on-the-revision-
of-the-EU-RoHS-Directive.pdf. 

122   Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, and Oman. 
123   Eurostat – data code ENV_WASTRDMP – 2020 / export / non-ferrous metal / EU 27. 

47 

 
 
 
The  EU  objectives  in  the  context  of  the  RoHS  Directive  are  still  relevant  and  are 
expected to remain so for the foreseeable future. These include the protection of human 
health and the environment from hazardous substances in waste EEE. 

The  objectives  of  the  RoHS  Directive  correspond  to  a  large  extent  to  the  current  and 
future  needs  of  the  EU  and  the  relevance  of  the  Directive  remains  high.  Some  aspects 
could be identified that can have a negative impact on the Directive’s future relevance, in 
particular the slow adaptation of restrictions and exemptions and the limited degree of 
flexibility to respond to new needs. 

This  section  covers  the  RoHS  Directive’s  suitability  to  respond  to  changes  and 
challenges in the EEE sector regarding the current hazardous substance restrictions and 
possible  future  restrictions,  and  to  current  and  foreseeable  challenges  linked  to  the 
treatment  of  WEEE.  The  initial  needs  that  led  to  the  formulation  of  the  Directive 
remain valid and the Directive still corresponds to these needs to a high extent. 

4.3.1  Identification of needs 

The  two  key  needs  linked  to  the  Directive’s  objectives  as  outlined  in  Article 1  are  to 
reduce and prevent the content of harmful substances in EEE to achieve the protection of 
human health and protection of the environment. Directly linked to these two needs – and 
to some extent necessary to fulfil them – are the requisites: 

• 
• 
• 

for a sound recovery and disposal of waste EEE; 
to take into account technological and scientific progress; and 
to ensure a well-functioning internal market. 

The need for a sound recovery and disposal of waste -EEE is covered in detail in the 
WEEE  Directive  (see  2.2  or  4.1.3.).  However,  harmful  substances  require  certain 
treatment activities to avoid exposure for workers and to avoid releasing emissions into 
the  environment.  Reducing  the  volume  of    harmful  substances  facilitates  the  sound 
recovery and disposal of WEEE to achieve a high recovery rate. 

New  developments  in  product  design  and  changes  in  manufacturing  processes  lead  to 
constant developments in the materials and substances used. It is therefore essential that 
the  RoHS  Directive  is  equipped  with  a  process  that  takes  account  of  technological 
progress  and  responds  to  it  accordingly.  On  the  one  hand,  this  may  involve  new 
evidence that certain substances should be classified as hazardous, and the need to drive 
technological  progress  towards  substituting  these  substances.  On  the  other  hand,  in  the 
exemption process, technological developments should also be assessed from the point of 
view  of  whether  use  of  the  substance  offers  considerable  benefits  that  justify  an 
exemption.  New  developments  in  trade  via  e-commerce  are  also  having  an  impact,  in 
particular on implementation and market surveillance. 

All these factors are put into the context of the increasing use of EEE in people’s daily 
lives. The volume of electrical and electronic equipment put on the market in the EU rose 
from 7.6 million tonnes in 2012 to a peak of 12.4 million tonnes in 2020 (see Figure 3)124. 
Though the RoHS Directive has banned many substances and contributed to  the phase-
out of those substances in EEE, it can be assumed that electrical appliances still contain 

124 Eurostat (env_waseleeos) and Eurostat (env_waselee). 

48 

 
 
 
hazardous  substances  that  would  need  to  be  tackled  to  protect  human  health  and  the 
environment. This includes looking at the stages of collection, recovery and disposal at 
end -of -life of these appliances. 

4.3.2  Correspondence between the Directive’s original objectives and the current and 

future environment, health and internal market needs 

Protecting  human  health  and  the  environment  and  safeguarding  the  functioning  of  the 
internal market are principles enshrined in the Treaties of the European Union and  they 
remain as  valid as  ever.  Collecting stakeholders’  views  on the correspondence between 
the  Directive’s  original  objectives,  how  well  they  reflected  and,  more  importantly, 
whether  they  still  reflect,  current  and  future  environmental,  technical,  economic,  and 
social  conditions  and  needs,  was  one  of  the  targets  of  the  OPC.  In  summary,  the 
consultation results on the need for EU legislation are as follows: 

•  protect human health: 73% (strongly) agree; 27% (strongly) disagree (N=101); 

•  protect the environment: 75% (strongly) agree; 25% (strongly) disagree (N=101). 

These  results  are  in  line  with  the  results  from  the  Member  State  consultation,  which 
found the majority were in strong agreement with these needs. 

The OPC results for the internal market were slightly more nuanced. 65% of 
respondents agreed and 35% disagreed (N=101). However, the majority of OPC 
respondents and all Member States (except one) affirmed the need for EU legislation on 
hazardous substances in EEE to ensure a well-functioning EU internal market. 

4.3.3  Aspects that may impact the RoHS Directive’s relevance 

The majority of private-sector stakeholders (n=57/N=101) did not see the need to change 
the list of restricted substances in Annex II to the RoHS Directive. Several respondents 
saw  the  need  to  either  list  new  substances,  de-list  existing  substances  or  change  the 
concentration  values  of  the  substances  that  are  currently  restricted.  The  feedback 
obtained from the Member State consultation showed that a large majority of respondents 
considered it necessary to update of the list of substances. 

New  substances  on  the  market  or  new  identified  hazards  of  substances  (e.g.  endocrine 
disruption or persistence) can pose risks to human health and the environment. A regular 
and efficient update of the list of restricted substances to tackle such risks would ensure 
that the Directive remains relevant. 

Given the increase in mechanical waste treatment as part of a circular economy, workers 
can be exposed to increasing levels of chemicals originating from WEEE. Depending on 
the  lifetime  of  the  EEE,  the  product  may  have  been  placed  on  the  market  before  the 
restrictions came into force (13 years for large household appliances (2005) or 30 years 
for  photovoltaic  panels),  which  can  increase  the  risk  for  workers.  The  timeline  for 
restrictions  coming  into  effect  lags  behind  the  potential  risks,  with  the  risk  that  the 
information  about  the  presence  of  hazardous  substances  in  WEEE  gets  lost  as  time 
passes. 

Another  timeframe-related  challenge  is  that  higher  ambition  for  recycling  can  interfere 
with  contaminated  waste  streams,  where  hazardous  substances  are  not  restricted  at  that 
time,  for  example  due  to  a  lack  of  efficiency  of  the  process.  However,  horizontal 
chemical legislation such as REACH can cover restrictions for EEE. 

49 

 
As  a  result  of  the  decision  taken  under  the  Basel  Convention  to  make  all  WEEE 
transboundary movements subject to the prior informed consent procedure, it is possible 
that more WEEE might be remain in and be treated within the EU in future. 

Stakeholders  view  the  exemption  process  as  indispensable  to  meet  the  specifics  of 
certain  products,  industries  and  manufacturing  processes.  However,  deficiencies  in  the 
exemption  process,  in  particular  issues  of  efficiency  (see  4.1.6),  can  have  a  negative 
influence  on  the  relevance  of  the  Directive.  The  process  must  strike  the  right  balance 
between  stringency  and  well-founded  criteria  for  an  exemption,  the  effort  required  to 
apply for an exemption and the effort required to carry out an adequate and thorough, but 
not too lengthy, evaluation of the application. 

So far, the objective is to achieve a gradual phase-out of hazardous substances in EEE. In 
the  past,  narrowing  the  scope  of  exemptions  could  lead  to  significant  savings  of 
hazardous substances. Today there are exemption requests for low volumes of hazardous 
substances, for example the application for exemption 37 in Annex IV indicated less than 
1  gram  of  lead.  Other  exemption  requests  only  apply  to  a  few  manufacturers,  such  as 
exemption 41 in Annex IV requested by one manufacturer for a single specific system. 
Given  the  efficiency  and  the  future  challenges  in  handling  more  individual  exemption 
requests,  it  is  questionable  whether  the  standard  procedure  for  time-limited  exemptions 
for such exemptions are adequate and whether the effort involved justifies the process. 

By  contrast,  some  exemptions  cover  many  tonnes  of  hazardous  substances,  such  as 
exemption 7(a) in Annex III for lead in high melting temperature solders covers between 
150  and  9 400  tonnes  of  lead  per  year.  For  other  exemptions,  there  is  evidence  of 
alternatives, but the socio-economic distortion for the market would be unacceptable for 
society. In these cases, an in-depth investigation could help make thorough decisions. 

There are other incentives used, other than regulatory measures, to reduce the volume of 
hazardous substances in EEE (see also the second support study). For example, there are 
requirements stemming from eco fee modulation under extended producer responsibility 
(e.g.  in  France),  a  chemicals  tax  for  certain  chemicals  in  EEE  (e.g.  in  Sweden)  or 
voluntary  agreements  or  requirements  in  the  supply  chain  adopted  by  more  ambitious 
companies to phase out hazardous substances (e.g. IBM or Hewlett-Packard). 

5  CONCLUSIONS AND LESSONS LEARNED 

The  RoHS  Directive  has  helped  to  reduce  hazardous  substances  in  EEE  in  the  EU. 
Collecting quantitative and reliable data on the reduction of hazardous substances in EEE 
is challenging. A quantitative estimate made in the evaluation study shows that there is a 
total  reduction  of  hazardous  substances  in  EEE  between  2003  and  2016,  even  though 
shortcomings  in  the  analysis  method  and  assumptions  lead  to  a  less  robust  quantitative 
result.  The  substance  restrictions  of  the  RoHS  Directive  alone  did  not  lead  to  this 
reduction.  

The  reduction  of  hazardous  substances  in  EEE  has  thus  increased  the  protection  of 
human  health  and  the  environment  at  different  stages  of  the  value  chain  (especially  in 
production and disposal). However, providing quantitative and reliable data to prove the 
positive impacts between the reduction of hazardous substances and the human health / 
the environment is difficult.  

The Directive has  also  contributed to  the harmonisation  and functioning  of the internal 
market  by  providing  uniform  rules  for  the  restriction  of  hazardous  substances  for 

50 

 
producers  of  EEE  in  the  EU.  These  were  taken  over  by  the  relevant  industry  sector. 
However,  inspections  by  enforcement  authorities  suggest  that  some  product  categories 
have high levels of non-compliance, which can mitigate the positive effects. In addition, 
exchanging compliance information along the supply chain poses problems in practice. 

The evaluation  process  also  concluded that the  Directive  remains relevant. The need  to 
protect human health and the environment and to contribute to the environmentally sound 
recovery and disposal of waste EEE by restricting of the use of hazardous substances in 
EEE  remains  relevant  and  will  continue  to  be  in  the  near  future.  The  Directive’s  EU 
added value is also prominent, and the evidence collected during the evaluation process 
suggests  that  the  same  level  of  harmonisation  could  not  have  been  achieved  in  the 
absence of the RoHS. 

Nevertheless,  there  are  aspects  that  work  less  well.  Regarding  innovation,  the  RoHS 
Directive  prompted  investments  in  finding  substitutes  for  hazardous  substances  that  in 
many  cases  led  to  the  development  of  alternatives.  However,  industry  perceives  the 
investments  associated  with  the  inclusion  of  medical  equipment  and  monitoring  and 
control  instruments  in  the  Directive’s  scope  as  considerable  due  to  their  area  of 
application and the comparatively long-life cycles of these product categories. In general, 
it was difficult to quantify the costs  for stakeholders as it is not possible to  disentangle 
the  costs  of  compliance  with  the  RoHS  Directive  and  separate  them  from  the  costs  of 
compliance with other legislation. 

The  evaluation  process  identified  a  need  to  clarify  and  improve  the  methodologies  for 
assessing exemptions and for reviewing and amending the list of restricted substances to 
give  stakeholders  more  certainty  on  the  grounds  for  restricting  new  substances  and  for 
adopting  exemptions.  In  addition,  the  methodologies  should  be  updated  to  reflect 
technological  developments  and  be  more  coherent  (consistent)  with  other  procedures 
under  legislation  governing  chemicals.  Increasing  the  robustness  and  efficiency  of  the 
process  would  help  maintain  stakeholder  confidence  in  the  process  and  ensure  a  high 
level  of  cooperation  between  all  parties  involved.  The  frequent  amendments  of  the 
Annexes pose an administrative burden for authorities and stakeholders, who questioned 
whether a directive was the most efficient legal form. 

The  process  also  flagged  the  need  to  clarify  some  definitions.  It  may  be  necessary  to 
revise the Directive’s provisions on scope exclusions to ensure that the selection of EEE 
excluded  from  the  Directive's  scope  is  sufficiently  clear  and  updated  in  line  with  the 
latest technical and economic developments. 

Regarding  external  coherence,  the  process  identified  overlaps  between  the  substance 
restrictions  laid  out  in  the  RoHS  Directive  and  similar  provisions  laid  down  by  the 
Ecodesign  Directive  or  the  REACH  and  POPs  Regulation.  For  example,  overlaps  or 
incoherencies  in  the  scope,  definitions,  limit  values  or  mechanisms  to  deviate  from  the 
restrictions may give rise to a fragmented regulatory landscape and, in some cases, to a 
lack of clarity and certainty for Member State authorities and industry. However, many 
perceived  coherence  issues  can  find  an  answer  in  legislative  and  non-legislative 
documents,  even  if  these  are  not  formulated  in  a  sufficiently  comprehensible  and 
transparent  manner  and  the  concerns  expressed  often  relate  only  to  individual  areas 
without  their  broader  impact  being  substantiated.  Finally,  the  RoHS  Directive  had 
remarkable  influence  beyond  European  Union  borders,  with  similar  laws  adopted  in 
approximately other 40 jurisdictions around the world. The Directive is considered to be 

51 

 
a  global  benchmark  for  reducing  toxic  substances  in  EEE,  with  potentially  significant 
environmental and health benefits worldwide. 

5.1  Lessons learned 

Overall, the RoHS Directive functions well. The restrictions have been implemented and 
have contributed to a reduction in the volume in hazardous substances in EEE. However, 
most  conclusions  were  made  on  qualitative  assessments.  There  is  a  need  to  introduce 
indicators,  which  are  reproducible  and  can  measure  progress  and  success  of  the  RoHS 
Directive. 

Some  aspects  in  the  Directive  need  to  be  updated  to  improve  coherence  and  to  reflect 
technical  developments  on  the  market.  There  is  a  need  to  inform  stakeholders  and  to 
provide guidance, in particular on the scope of the Directive or the exemption procedure.  

The  evaluation  highlighted  that  the  processes  for  deciding  on  exemptions  and  updating 
substance restrictions under the RoHS Directive are to some extent lacking transparency 
and efficiency and can be improved in terms of scientific robustness. In addition, revising 
the  Directive  in  the  future  can  be  an  opportunity  to  simplify,  to  streamline  with  other 
legislations and to align with other policy objectives. 

52 

 
6  ANNEX I: PROCEDURAL INFORMATION 

Lead DGs and internal references 

The  evaluation  (PLAN/2018/3000)  has  been  coordinated  by  the  European  Commission’s 
Directorate-General  (DG)  for  Environment,  supported  by  an  interservice  steering  group 
(ISG) 
involving  representatives  of  DG  Communications  Networks,  Content  and 
Technology, DG Internal Market, Industry, Entrepreneurship and SMEs, DG Energy, DG 
Justice  and  Consumers,  DG  Research  and  Innovation,  the  Joint  Research  Centre,  DG 
Taxation and Customs Union, DG Trade, DG  Health and Food Safety, the Legal Service 
and the Secretariat-General. The group steered and monitored the evaluation's progress and 
ensured that it met the necessary standards for quality, impartiality and usefulness. 

Organisation and timing 

The  Commission  published  a  roadmap125  for  the  evaluation  of  the  RoHS  Directive  on 
14 September 2018; feedback on this roadmap was received until 12 October 2018. 

The  consultation  strategy  was  published  jointly  with  the  publication  of  the  RoHS 
Directive’s  evaluation  roadmap,  mentioned  above.  The  strategy  set  out  a  number  of 
consultation  activities,  comprising  a  public  consultation  and  targeted  consultation  in  the 
form  of  interviews  and  surveys.  While  a  detailed  consultation  synopsis  is  provided  in 
Annex V, a brief explanation of consultation activities follows here. 

To  maximise  stakeholder  engagement,  the  evaluation  followed  the  targeted  consultation 
approach. In this context, the OPC was launched on 13 September 2019 and remained open 
for  12  weeks  until  6 December  2019  to  obtain  input  on  the  questions  examined  in  the 
report.  In  total,  163  responses  were  collected.  In  parallel  to  the  OPC,  an  in-depth  survey 
(questionnaire)  was  shared  with  Member  State  authorities  involved  in  implementing  the 
RoHS Directive. 

 Between October 2019 and March 2020, three focus groups were organised, covering the 
following  topics:  (i)  assessment  of  the  Directive’s  implementation  and  enforcement;  (ii) 
effectiveness  and  efficiency  –  environmental  and  health  aspects;  (iii)  effectiveness  and 
efficiency  –  costs  and  benefits  aspects;  and  (iv)  external  and  internal  coherence.  In  the 
same  period,  in-depth  interviews  were  organised  with  stakeholders,  partly  as  follow-up 
interviews to input provided via the OPC. 

A  workshop  was  held  towards  the  end  of  the  study,  in  March  2020,  to  present  the 
preliminary  findings  of  the  study  and  provide  stakeholders  with  another  opportunity  to 
provide their input. 

To  supplement  input  from  the  stakeholder  consultation,  a  stakeholder  workshop  was 
organised in  March  2020 (online, due to the  COVID-19  restrictions). The workshop  was 
attended  by  125  stakeholders  from  public  authorities,  industry  representatives  (economic 
operators  and  their  representatives  at  EU  and  national  level)  and  other  stakeholders, 
including NGOs and academic experts. 

125 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1891-Hazardous-substances-in-

electrical- electronic-equipment-evaluation-of-restrictions_en 

53 

 
 
 
Exceptions to the Better Regulation guidelines 
No exceptions were made to the Better Regulation guidelines126 during this evaluation. 

Evidence, sources and quality 

The  evaluation  was  supported  by  a  study  that  among  other  things  provided  support  on 
stakeholder  consultation.  This  study  was  launched  in  March  2019  and  performed  by  a 
consortium led by Ecorys127. The study was completed in March 2021128. 

The following key studies and reports were taken into account: 

• 
legal acts and documents related to the Directive’s implementation129; 
•  studies and report related to exemption and restriction assessment130. 

7  ANNEX II. METHODOLOGY AND ANALYTICAL METHODS USED 

This annex provides a brief and transparent account of the methods and sources employed 
during the RoHS Directive evaluation, including the limitations (e.g. data) encountered. 

Central  to  the  methodology  used  during  the  evaluation  process  were  the  evaluation 
questions  (and  sub-questions)  developed  on  the  basis  of  the  five  evaluation  criteria: 
effectiveness, efficiency, coherence, relevance and EU added value. To gather information 
and  data  to  enable  a  thorough  analysis  of  the  Directive’s  operation  and  progress,  the 
following main sources were used by the Ecorys-led consortium who provided the support 
study: 

literature review 

• 
•  desk and databases research 
•  stakeholder consultation, including interviews and targeted surveys 
• 
• 
• 

focus groups 
reports by market surveillance authorities 
legal, policy and technical sources 

The analytical approach to evaluate the Directive included: 

triangulation of stakeholders’ views 

•  analysis of consultation findings 
• 
•  qualification and quantification of costs and benefits estimates 
•  etc. 

126 https://ec.europa.eu/info/better-regulation-guidelines-and-toolbox_en 

127 Study ‘Support for the evaluation of Directive 2011/65/EC on the restriction of the use of certain hazardous 
substances in electrical and electronic equipment (RoHS)’ commissioned by DG Environment under the Implementing 
Framework contract No ENV.F.l/FRA/2014/0063. 

128https://publications.europa.eu/en/publication-detail/-/publication/926420bc-8284-11e9-9f05-01aa75ed71a1/language-
en/format-PDF. 

129 https://ec.europa.eu/environment/topics/waste-and-recycling/rohs-directive_en#ecl-inpage-617. 

130 See consultant final reports published at https://ec.europa.eu/environment/topics/waste-and-recycling/rohs-
directive_en#ecl-inpage-621. 

54 

 
 
 
Unfortunately, data collection proved to be a significant challenge which impacted the 
quality of the analysis and robustness of findings. For instance: 

•  Data  is  lacking  on  the  concentration  of  hazardous  substances  in  EEE  waste  per 
category  of  product,  and  there  was  insufficient  data  available  on  the  weight  of  the 
‘homogeneous materials’ in the EEE for which the maximum concentration values are 
regulated. 

•  Availability of data is limited both for the period before and around implementation of 
the  RoHS  Directive,  as  well  as  for  more  recent  years.  It  was  not  possible  to  collect 
precise information from the literature review or through interviews. Some interviewed 
stakeholders and participants in the focus groups indicated this could be due to the lack 
of  a  reliable  monitoring  framework  in  place  before  the  first  RoHS  Directive 
(2002/95/EC) and the fact that a relevant amount of RoHS-compliant equipment placed 
on the market might have not yet reached end of life. Therefore, estimations had to be 
made. 

•  As regards the data on costs and benefits: 

•  Companies were not able to provide a precise estimate of the percentage of turnover 
spent  on  RoHS  compliance  both  in  terms  of  their  initial  investment  cost  and 
operating expenditure. Therefore the data was not sufficient to put together an overall 
assessment of the costs, but sufficient to put together an estimate of the costs. 

•  Companies  found  it  easier  to  provide  FTE  estimates,  the  highest  estimates  having 

been provided by businesses representing EEE categories 3, 8 and 9131. 

•  The  quantification  of  benefits  was  to  a  large  extent  not  possible  due  to  the  lack  of 
precise data on the reduced amount of all hazardous substances as a consequence of 
the RoHS Directive. 

Robustness of analysis and conclusions 

The  input  provided  by  stakeholders  during  the  consultation  process  remained  limited  for 
some  important  data  The  data  limitations  outlined  above  put  a  substantial  strain  on  the 
analysis.  To  address  possible  information  and  data  gaps,  after  completion  of  the  OPC,  a 
stakeholder workshop was organised to present the initial findings and test them against a 
broad range of stakeholders. Triangulation of sources played a critical role in ensuring that 
the findings  were robust. Where primary data was not  available, the evaluation  relied on 
literature and expert opinions. As a result, and on the basis of the additional input received, 
the evaluation was accordingly refined and, where necessary, revised. The report needs to 
be read with these caveats in mind – while the report cannot provide a precise assessment, 
the findings reflect the order of magnitude of the impacts. 

131 Annex I of the RoHS Directive lays down the 11 categories of EEE covered by this  Directive, as follows: 1. Large 
household  appliances;  2.  Small  household  appliances;  3.  IT  and  telecommunications  equipment;  4.  Consumer 
equipment;  5.  Lighting  equipment;  6.  Electrical  and  electronic  tools;  7.Toys,  leisure  and  sports  equipment;  8. 
Medical devices; 9. Monitoring and control instruments including industrial monitoring and control instruments; 10. 
Automatic dispensers; 11. Other EEE not covered by any of the categories above. 

55 

 
 
 
8  ANNEX III. EVALUATION MATRIX AND DETAILS ON ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION) 

This annex presents the evaluation matrix which served as the organising framework of the evaluation work and answers to the questions by evaluation 
criterion. All the evaluation criteria – effectiveness, efficiency, relevance, coherence and EU added value – are addressed in the matrix. The analysis and 
evidence collected via the matrix provided the main points substantiating the assessment in Section 4 – Evaluation findings. 

Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Analysis (cross-
reference) 

Data sources 

Effectiveness 

56 

 
Analysis (cross-
reference) 

Data sources 

Evaluation 
staff 
working  document 
(‘Evaluation 
SWD’)  –  Section 
4.1 

Databases 

stakeholder 

Key 
interviews/focus 
groups 

Evaluation 
pp. 46-59.  

study, 

Targeted surveys 

Public 
consultation 
Relevant literature 

Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Question  1:  What  have 
been  the  (quantitative  and 
qualitative)  effects  of  the 
RoHS Directive? 

trade 

Trends in the production 
and 
of  EEE 
hazardous 
containing 
substances 

There 
is  a  clear 
decline  in  trends  in 
the  use  and  trade  of 
substances 

1.1  What  have  been  the 
and 
(quantitative 
qualitative)  effects  of  the 
RoHS  Directive  on  trends 
in the production and trade 
containing 
of 
hazardous  substances,  and 
the  recovery  and  disposal 
of EEE waste? 

EEE 

Volume  of  hazardous 
recovered 
substances 
and 
of 
adequately 

disposed 

of 

Estimate 
the 
proportion of EEE waste 
which  actually  causes 
harm  to  human  health 
and the environment 

There is a clear trend 
in 
the  volume  of 
substances  recovered 
and 
of 
disposed 
adequately 

The RoHS restrictions on use of hazardous 
substances  in  EEE  have  contributed  to 
the  amount  of 
reducing  significantly 
hazardous  substances  put  on  the  EU 
market. Such reduction is also reflected in 
electronic waste, as the WEEE stream will 
hazardous 
substances. 
less 
contain 
Consequently, 
management 
waste 
processes  may  become  safer,  although 
there 
limited  quantitative 
is  currently 
evidence to confirm this. 

Beyond  its  specific  objectives  to  reduce 
hazardous  substances,  RoHS  contributed 
to  innovation  by  pushing  for  substitution 
towards  reliable,  non-toxic  EEE  and  their 
components.  By  reducing  the  amount  of 
hazardous  substances  in  EEE  and  by 
allowing  (under  specific  conditions)  the 
reuse  and  repair of spare  parts, the  RoHS 
Directive also positively contributed to the 
objectives  of  the  EU  Circular  Economy 
Action Plan. 

Finally,  the  Directive  has  paved  the  way 
for RoHS-like legislation to be developed 

57 

 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Analysis (cross-
reference) 

Data sources 

around  the  world.  In  fact,  the  RoHS 
example is looked upon and ‘imitated’ by 
numerous countries. 

1.2  Beyond  the  objectives 
of the Directive, what other 
significant  changes,  both 
negative, 
and 
positive 
could  be 
the 
linked 
Directive, if any? 

to 

of 

Opinion 
the 
stakeholders  on  other 
unexpected 
positive/negative 
changes  resulting  from 
the Directive 

Positive/negative 
changes 
resulting 
the  Directive 
from 
are  identified,  such 
as market innovation 

1.3  What  has  been 
impact  of 
outside of the EU? 

the 
the  Directive 

of 

Evidence/examples 
positive/negative 
changes  resulting  from 
the  Directive  outside  of 
the EU (e.g. adoption of 
similar  legislation,  with 
economic, 
consequent 
social 
and 
environmental impacts)  

Identified 
positive/negative 
resulting 
changes 
from 
the  Directive 
outside  of  the  EU, 
such  as  the  adoption 
of similar legislation, 
and related impacts 

of 

the 
Opinion 
stakeholders on the level 
the 
of  compliance 
obligations 
the 
Directive 

of 

to 

Question  2:  To  what 
extent  have  the  objectives 
of the RoHS Directive been 
achieved? 

2.1  To  what  extent  have 
manufacturers, 
importers, 
distributors  and  authorised 
representatives  in  the  EU 
and  its  Member  States met 
their obligations? 

agree 
Stakeholders 
that  manufacturers, 
importers, 
distributors 
authorised 
representatives in the 
EU  and  its  Member 
States  met 
their 
obligations 

and 

No  cases  of  non-
compliance  of  EU 
Member States 

Evidence points to different approaches to 
conduct  market 
across 
Member States. This results in often non-
comparable  results  regarding  compliance 
levels. 

surveillance 

By  reducing  the  amount  of  hazardous 
substances in EEE products placed on the 
market,  RoHS  has  had  a  positive  impact 
on  the  environment  and  human  health  in 
Europe and in developing countries where 
informal recycling processes are the norm. 

Evaluation  SWD  – 
Section 4.1 

stakeholder 

Key 
interviews/focus 
groups 

Evaluation 
pp. 60-72. 

study, 

Targeted surveys 

Public 
consultation 

Reports by market 

58 

 
 
 
 
 
 
Analysis (cross-
reference) 

Data sources 

surveillance 
authorities 

Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

on 

the 

majority 

of 
A 
agree 
stakeholders 
negative 
that 
human 
effect 
the 
health 
environment 
of 
controlled  hazardous 
substances  in  EEEs 
has been reduced due 
to the Directive 

and 

By  introducing  harmonised  restrictions, 
the  Directive  created a  level  playing  field 
thus  effectively 
for  all  manufacturers 
contributing  to  the  proper  functioning  of 
the internal market. Despite the difficulties 
presented  by  different  approaches  for 
the 
enforcing 
implementation  of  the  Directive  in  the 
Member  States,  it  can  be  concluded  that 
compliance levels are high. 

monitoring 

and 

One  key  aspect  has  been  identified  as 
having  hindered  the  effectiveness  of  the 
Directive:  the  exemption  process,  due  to 
its complexity and length. 

Stakeholders 
agree 
that the Directive has 
led 
the 
to 
establishment  of  a 
level  playing 
field 
for all manufacturer 

No cases of distorted 
competition 

2.2  Has 
the  Directive 
contributed 
to  protecting 
the 
human  health  and 
environment,  including  via 
the  environmentally  sound 
recovery  and  disposal  of 
waste EEE? 

2.3  Has 
the  Directive 
contributed  to  the  proper 
functioning  of  the  internal 
relevant 
for 
market 
products,  establishing  a 
level  playing  field  for  all 
manufacturers, 
their 
independently 
origin  (EU  or  non-EU), 
size,  or  market  type  (i.e. 
primary or secondary)? 

of 

of 

on 
of 

Opinion 
the 
stakeholders 
the 
the 
contribution 
Directive  to  health  and 
environmental 
objectives 

of 

on 
of 

the 
Opinion 
the 
stakeholders 
contribution 
the 
Directive  to  the  proper 
the 
functioning 
of 
internal  market 
for 
relevant products 

that 

Evidence 
the 
Directive  has  led  to  the 
establishment  of  a  level 
playing 
for  all 
field 
manufacturers  between 
EU Member States 

2.4  Which  main  factors 
(e.g. 
implementation  by 
Member  States,  actions  by 
have 
stakeholders) 

Influence 
measures 
Directive 

of 
of 

the 
the 

that 

Evidence 
the 
measures  contributed 
the 
achieving 
to 
the 
of 
objectives 

59 

 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Analysis (cross-
reference) 

Data sources 

contributed  to,  or  stood  in 
the  way  of  achieving  any 
of  the  objectives  of  the 
Directive 
the 
within 
expected timeframe? 

Degree  of  influence  of 
the 
the  measures  of 
Directive 

Influence  of  external 
factors 

Degree  of  influence  of 
external factors 

Directive,  consistent 
with 
intervention 
logic 

Stakeholders 
agree 
that  the  measures  of 
the  Directive  have 
played  an  important 
role 

that 
Evidence 
factors 
external 
to 
contributed 
the 
achieving 
objectives 
the 
Directive,  consistent 
with  the  intervention 
logic 

of 

agree 
Stakeholders 
that  external  factors 
have played a role 

Efficiency  

Question  3:  What  are  the 
benefits 
costs 
non-
(monetary 
monetary)  associated  with 

and 

and 

RoHS  1 
implemented 
but  not  RoHS  2  (social 
benefits  or  costs  arise 
from  the  difference  of 

or 
Stakeholders 
identify 
literature 
differences 
cost 
between  Member 

led 

The  RoHS  Directive 
to  wider 
environmental and health benefits, such as 
reducing  damage  to  the  environment  and 
human  health.  The  RoHS  Directive  also 

Evaluation  SWD  – 
Section 4.1 

Targeted survey 

Key 

stakeholder 

60 

 
 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Analysis (cross-
reference) 

Data sources 

the  implementation  of  the 
Directive since its adoption 
in  2011  for  the  different 
stakeholders, 
economic 
actors  in  all  stages  of  the 
EEE  life  cycle  and  society 
at large, at national and EU 
level? Are there significant 
distributional 
differences 
between Member States? 

the 
and 
actual 
baseline scenario) 

the 

States 

of 

or 
Stakeholders 
identify 
literature 
drivers 
cost 
differences  between 
Member  States  and 
how  these  relate  to 
the 
of 
state 
implementation 

Direct 
Decrease 
morbidity, 
ecosystem 
resource efficiency 

benefits: 
of 
human 
increase  of 
services, 

adoption 

Indirect  benefits:  third-
of 
country 
legislation  based  on  the 
RoHS  Directive,  and 
social, 
related 
and/or 
environmental 
economic benefits 

Stakeholder  opinions  on 
the  what  the  benefits  of 
the Directive are 

of 

Evidence  of 
specific 
examples 
cost 
differences 
or 
between 
congruence 
Member  States,  with  a 
of 
graphic 
results 
quantitative 
where appropriate 

display 

interviews/focus 
groups 

Public 
consultation 

Relevant literature 

to  economic  benefits 

led 
such  as 
increasing  the  level  playing  field  for 
businesses in the internal market, creating 
legal  certainty,  and  sometimes  spurring 
innovation through substitution. 

Evaluation 
pp. 73-84. 

study, 

reviewing 

The  compliance  costs  of 
the  RoHS 
Directive for businesses include collecting 
information,  gathering 
and 
supply  chain  information,  costs  related  to 
a  dedicated  IT  system  to  manage  all 
required  pieces  of  information,  and  costs 
related to the exemption system. 

The technical costs for businesses include 
complying  with  the  hazardous  substances 
restrictions  in  their  product  (i.e.  product 
development).  The  highest  costs  seem  to 
be  related  to  the  exemption  system  and 
product  development 
to  comply  with 
substance restrictions. 

As  the  Directive’s  scope  widened,  more 
investment  in  research  and  development 
was  needed  for  some  businesses  and  thus 
additional  costs  were  incurred  due  to  the 
increased scope of substances and EEE. 

The 

enforcement  of 

the 

substance 

61 

 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Analysis (cross-
reference) 

Data sources 

are 

the 

Question  4:  To  what 
extent 
costs 
justified, given the benefits 
the  RoHS  Directive  has 
delivered? 

5: 

Question 
proportionate  were 
costs 
stakeholder groups? 

for 

How 
the 
different 

Evidence  of  the  drivers 
and  consequences  of 
cost  drivers  between 
Member States 

restrictions  appears  to  be  the  largest  cost 
driver.  It  is  important  to  note  that  both 
businesses  and  Member  State  competent 
authorities found it difficult to disentangle 
the costs for the RoHS Directive from the 
costs  associated  with  other  compliance or 
enforcement  activities  related  to  EEE. 
There  is  not  sufficient  data  to confidently 
state  that  there  are  differences  among 
Member States. 

Benefit-cost ratio 

Opinion  of  stakeholders 
whether  the  costs  of  the 
Directive are justified by 
the benefits delivered 

Benefits exceed costs  Based on the analysis undertaken it could 
be  concluded  that  benefits  (especially  the 
environmental  and  health  benefits)  of  the 
RoHS  Directive  outweigh  the  Directive’s 
costs  (to  businesses  and  Member  State 
authorities).  Stakeholders  also  generally 
agree  that  costs  of  the  Directive  are 
justified. 

Evaluation  SWD  – 
Section 
4.1Evaluation 
study, pp. 84-85. 

Cost  estimate  broken 
down  by  source  and 
type  of  economic  sector 
involved (e.g. producers, 
recyclers,  manufacturers 
and 
re-manufacturers, 
and authorities) 

Share  of  stakeholders 
agreeing  that  the  costs 

Varying  proportion 
of  costs  relative  to 
turnover 
each 
respective sector 

of 

The  majority 
stakeholders 
that 
justified 

of 
agree 
the  costs  are 
the 
by 

and 

electronic 

Based  on  the  available  evidence,  the 
majority  of 
the  RoHS 
the  costs  of 
Directive  lie  with  the  manufacturers  of 
electrical 
equipment. 
Furthermore,  a  significant  cost  of  the 
RoHS  Directive  also 
the 
competent  authorities  and  enforcement 
agencies. Based on the estimates provided 
by  businesses,  there  are  indications  that 
manufacturers  in  categories  3,  8  and  9 

lies  with 

Evaluation  SWD  – 
Section 4.1 

Evaluation 
pp. 85-88. 

study, 

Targeted survey 

stakeholder 

Key 
interviews/focus 
groups 

Public 
consultation 

Relevant literature 

Targeted survey 

stakeholder 

Key 
interviews/focus 
groups 

62 

 
 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

justified  by 

are 
benefits 

the 

benefits 

Question  6:  How  efficient 
has  the  exemption  system 
from  substance  restrictions 
been?  

Costs  associated  with 
inefficiencies  from  the 
review  and  exemption 
(e.g. 
system 
administrative  burden, 
lack 
flexibility, 
responsiveness) 

of 

High  level  of  costs 
caused by review and 
exemption system 

Inefficiencies 
identified 

are 

for 
Reasons 
inefficiencies 
the 
review  and  exemption 
system 

in 

Expected 
inefficiencies 
absent 

savings 

if 
were 

relatively 

bear 
costs 
manufacturers in other categories. 

higher 

Analysis (cross-
reference) 

Data sources 

than 

from 

literature 

The  substance 
restrictions  exemption 
system has been found to be complex and 
inefficient in a couple of ways. Firstly, the 
administrative  burden  associated  with  the 
exemption system is seen to be significant, 
although  there  is  not  enough  available 
evidence 
and 
the 
stakeholder  consultation  to  quantify  this 
cost.  Secondly,  the  process  of  handling 
exemption  requests  is  said  to  be  slow. 
These  factors 
the 
manufacturers. A number of key areas for 
improvement  of  the  exemption  system 
have  been 
identified  by  stakeholders. 
These areas have varying implications for 
businesses, 
compliance 
implementation  costs  for  the  European 
Commission and costs to society. 

to  costs  for 

costs 

lead 

for 

Evaluation  SWD  – 
Section 4.1 

Targeted survey 

Evaluation 
p. 89–92. 

study, 

stakeholder 

Key 
interviews/focus 
groups 

Interviews 

Public 
consultation 

legal 

Question 7: Is the form of 
instrument 
the 
(directive)  the  best  fit  to 
efficiently  achieve  the  set 
objectives? 

Description  of  other 
possible  types  of  legal 
instruments  that  could 
have  achieved  the  same 
result 

Identification 
of 
of 
other 
instruments  and  their 
relative efficiency 

types 

Description 

of 

the 

There is not a clear conclusion on whether 
another form of legal instrument would be 
a better fit to achieve the objectives under 
the  Directive.  There  are  good  arguments 
that  a  regulation  could  be  more  efficient 
than  a  directive  in  restricting  hazardous 
in  EEE  because  an  EU 
substances 

Evaluation  SWD  – 
Section 4.1 

Targeted survey 

Evaluation 

study, 

stakeholder 

Key 
interviews/focus 
groups 

63 

 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

of 

other 
likelihood 
instruments 
achieving 
the same result or better 
than a directive 

regulation  is  more  efficient  at  handling 
frequent updates of the legislation than an 
EU  directive.  However,  there  are  also 
good  arguments  that  the  Directive  works 
well and that administratively a regulation 
could 
different 
still 
enforcement practices. 

open 

be 

to 

Analysis (cross-
reference) 

Data sources 

pp. 92-93. 

Relevant literature 

have 

delivery 

Question  8:  What  factors 
could 
improved 
efficiency by strengthening 
the 
the 
while 
objectives 
unnecessary 
minimising 
avoiding 
and 
costs 
administrative burden? 

of 

that 

Opinion  of  stakeholders 
indicating 
the 
Directive  has  caused 
unnecessary 
regulatory 
burden or complexity 

The  same  examples 
of 
unnecessary 
regulatory  burden  or 
complexity 
are 
identified by multiple 
stakeholders 

Description 
of  most 
relevant  examples  of 
regulatory  burden  and 
creating 
complexity, 
unnecessary 
regulatory 
costs 

of 

Elements 
the 
Directive  that  could 
be  simplified  or  are 
superfluous 
are 
identified 

caused 

The  evidence 
the  consultation 
from 
activities  suggests  that  the  Directive’s 
some 
has 
implementation 
unnecessary burden and complexity.  As a 
result,  a  number  of  areas  of  possible 
improvement  for  the  Directive  have  been 
identified. These suggestions are related to 
the  need  to  have  more  guidance  on  the 
FAQ document, the exemption system, the 
way  the  Directive  is  implemented  and 
enforced, as well as the overlaps between 
RoHS and other legislative instruments. 

Evaluation  SWD  - 
Section 4.1 

Targeted survey 

Evaluation 
pp. 93-96. 

study, 

stakeholder 

Key 
interviews/focus 
groups 

Public 
consultation 

Desk research 

and 

good 

Qualitative  descriptions 
of 
bad 
practices emerging from 
stakeholder 
consultations 

the 
Practices 
in 
of 
implementation 
Directive 
the 
by 
described 
stakeholders  emerge 
as  overly  costly,  or 
on 
contrary, 
particularly efficient 

the 

64 

 
 
 
 
 
 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Analysis (cross-
reference) 

Data sources 

Coherence 

Question  9:  To  what 
the  RoHS 
extent 
Directive 
internally 
consistent and coherent? 

is 

Existence of gaps within 
the Directive 

There  are  no  gaps 
within the Directive 

The  main  issue  of  internal  coherence 
concerns  the  lack  of  clarity  regarding  the 
methodology to be applied for: 

Evaluation  SWD  – 
Section 4.1 

Legal,  policy  and 
technical sources 

of 
Existence 
contradictions,  overlaps 
or  missing  links  within 
the Directive 

no 

are 
There 
contradictions, 
overlaps  or  missing 
links  within 
the 
Directive 

of 

▪  Article 5: 

the 
adaptation 
Annexes  III  and  IV  (exemptions) 
to scientific and technical progress 
▪  Article 6: Review and amendment 
of  list  of  restricted  substances  in 
Annex II 

issues  of 

Minor 
internal  coherence 
concern  the  unclear  definitions  for  large-
scale stationary industrial tools (LSIT) and 
(LSFI). 
large-scale 
guidance 
Further 
or 
concerning 
these  definitions  may  be 
necessary. 

clarification 

installation 

fixed 

Evaluation 
pp. 98-101. 

study, 

Targeted survey 

stakeholder 

Key 
interviews/focus 
groups 

Public 
consultation 

is 

Question  10:  To  what 
the  RoHS 
extent 
Directive  coherent  with 
other  EU  environmental 
in 
policy 
the 
particular 
and 
WEEE  Directive 

objectives, 
those  of 

Some  Member  States  have  indicated  that 
the  scope  of  RoHS  may  require  some 
adaptation or clarification. 

Existence 
of 
contradictions,  overlaps 
or  missing  links  with 
other 
sectoral 
instruments  (e.g.  POPs 
Battery 
Regulation, 

EU 

no 

There 
are 
contradictions, 
overlaps  or  missing 
links  with  other  EU 
sectoral instruments 

the 
in 

The  overlap  between 
substance 
the  RoHS 
laid  down 
restrictions 
Directive  and  those  laid  down  in  the 
REACH  Regulation, 
the  Ecodesign 
Directive  and  the  POPs  Regulation  has 
been  found  to  be  the  main  external 

Evaluation  SWD  – 
Section 4.1 

Legal,  policy  and 
technical sources 

Evaluation 

study, 

Targeted survey 

65 

 
 
 
 
 
 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

circular  economy  policy, 
covering 
waste 
management,  the  use  of 
chemicals 
as 
product design? 

as  well 

Directive…) 

Existence 
of 
contradictions,  overlaps 
or missing links with the 
processes 
regulatory 
under REACH 

that 

the 
Evidence 
common  understanding 
paper addresses overlaps 
between    REACH  and 
the Directive  

no 

There 
are 
contradictions, 
overlaps  or  missing 
the 
links  between 
Directive  and 
the 
regulatory  processes 
under REACH 

The 
common 
understanding  paper 
of  REACH  and  the 
Directive 
are 
compatible 

issue.  These  acts  contain 
coherence 
mechanisms  which  can 
the 
presence  of  certain  substances,  which 
would also affect EEE. 

restrict 

However,  this  legislation  also  contains 
mechanisms 
different 
considerably 
regarding,  for  example,  the  identification 
of  substances  for  restriction,  limit  values 
and exemptions. 

that 

Stakeholders 
such 
indicated 
differences  may  lead  to  legal  uncertainty. 
Further  clarification  on  the  delimitation 
between  the  substance  restrictions  under 
RoHS and substance restrictions under the 
mentioned overlapping legislation may be 
necessary. 

Analysis (cross-
reference) 

pp. 101-114. 

Data sources 

stakeholder 

Key 
interviews/focus 
groups 

Public 
consultation 

Relevance 

66 

 
 
 
 
 
 
 
Analysis (cross-
reference) 

Data sources 

Evaluation  SWD  – 
Section 4.3 

Relevant literature 

Evaluation 
pp. 115-122. 

study, 

stakeholder 

Key 
interviews/focus 
groups 

Public 
consultation 

Targeted survey 

Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

to  exist  at 

The needs of the EU in the context of the 
RoHS  Directive  are  still  valid  and  will 
the 
continue 
foreseeable  future.  These  include,  among 
others, the protection of human health and 
hazardous 
the 
substances in EEE and waste EEE. 

environment 

from 

least 

into 

The analysis showed that the objectives of 
the  RoHS  Directive  correspond to  a  large 
extent  to  these  needs  of  the  EU  and  that 
the  Directive’s  relevance  is  still  high. 
Some  aspects  could  be  identified that  can 
have a negative impact on the Directive’s 
future 
the 
frequency of updating the list of restricted 
substances,  which  is  considered  by  some 
stakeholders  as  too  infrequent.  Another 
aspect 
coherence 
(consistency) with other legislation, which 
detracts from the Directive’s relevance. 

relevance.  This 

includes 

(partial) 

the 

is 

Question  11:  To  what 
extent  do  the  objectives  of 
Directive 
the 
correspond  to  the  needs  of 
the EU? 

RoHS 

11.1:  How  well  do  the 
original  objectives  of  the 
Directive  correspond 
to 
current 
environmental, 
technical,  economic  and 
social 
and 
conditions 
needs,  with  regards  to  the 
use  of  EEE,  and  their  end-
of-life treatment within the 
EU? 

the  RoHS 
11.2:  Does 
Directive  still  effectively 
address  the  most  relevant 
hazardous  substances  used 
in  EEE  and  set  relevant 
standards  and  obligations 

Stakeholders’  opinions 
original 
on  whether 
are 
objectives 
to  meet 
(in)sufficient 
needs  of  key 
target 
groups 

in 
types  of 

Evidence  found 
different 
documents 
confirming  whether 
the 
Directive 
supports/contradicts 
new developments 

of 

Description 
environmental, 
technical, economic, and 
social  trends  in  the  EU 
and their impact on EEE 
use  and  their  end-of-life 
handling  (e.g.  circular 
economy 
and  waste 
management 
requirements) 

of 

Description 
the 
development  of  EEE 
and 
treatment 
waste 
recycling 
technologies 
since the adoption of the 
Directive 

Stakeholders  are  of 
the opinion that their 
needs are met 

Stakeholders  make 
reference  to  fact  that 
original 
objectives 
are  (in)sufficient  to 
meet  needs  of  key 
target groups 

agree 
Stakeholders 
that  standards  set  to 
protect health and the 
environment 
are 
appropriate 

Development  of  EEE 
and 
manufacturing 
treatment techniques 

Stakeholders 
agree 
that  the  measures  of 

67 

 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Analysis (cross-
reference) 

Data sources 

to  protect  human  health 
and the environment? 

11.3:  How  relevant  are  the 
provisions  of  the  Directive 
to 
its 
achieving 
environmental objectives? 

11.4:  To  what  extent  do 
problems  addressed  by  the 
Directive 
persist 
within the EU? 

still 

the 
Question  12:  Has 
RoHS  Directive 
been 
flexible  enough  to  respond 
to new issues? 

the  Directive  address 
environmental 
of 
objectives 
Directive 

the 

The  extent  to  which  the 
articles  of  the  Directive 
to 
are 
still 
achieving 
the 
environmental 
objectives 

relevant 

new 

Development and/or use 
of 
hazardous 
substances in EEE, or of 
and 
new 
hazards, 
technical 
subsequent 
waste 
management 
requirements 

hazardous 
New 
substances in EEE or 
new 
and 
risks 
practices  associated 
with  substances  are 
covered 
the 
Directive 

by 

flexibility 
Degree  of 
the 
allowed  within 
Directive 
to 
technical  and  scientific 
progress  (i.e.  Article 5 
and 6 

to  adapt 

and 

Technical 
scientific 
that 
developments 
the 
should 
scope 
the 
Directive  have  been 
addressed 

affect 
of 

identified  during 

The RoHS Directive has not been flexible 
enough 
to  all 
to  respond  adequately 
developments  in  recent  years.  The  most 
notable  aspects 
the 
evaluation are issues about the exemption 
process,  which  is  seen  as  too  slow,  too 
time-consuming  for 
complex  and 
companies.  These 
certain 
the 
sometimes  serious  deficiencies 
process  reduce  the  Directive’s  relevance. 
The exemption process was pointed out as 
a  type  of  bottleneck  that  creates  planning 
uncertainty  in  the  industry  due  to  the 
reason that it is carried out too slowly. 

too 
(smaller) 

in 

Evaluation  SWD  – 
Section 4.3 

Desk research 

Evaluation 
pp. 122 – 126. 

study, 

stakeholder 

Key 
interviews/focus 
groups 

Targeted survey 

EU added value 

68 

 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis (cross-
reference) 

Data sources 

Evaluation  SWD  – 
Section 4.2 

Public 
consultation 

Evaluation 
pp. 127-133. 

study, 

stakeholder 

Key 
interviews/focus 
groups 

Relevant literature 

Stakeholder 
conference 

Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

RoHS 

Question  13:  What  is  the 
added  value  resulting  from 
Directive 
the 
compared  to  what  is  likely 
to  have  been  achieved  by 
the  Member  States  in  its 
absence? 

of 

Description 
the 
situation  where  there  is 
no  EU  Directive  and 
States 
Member 
implement 
relevant 
legislation  at  national 
level 

Stakeholders  identify 
Directive’s 
the 
in 
additional  value 
terms 
higher 
of 
benefits,  lower  costs, 
evidence  /  examples 
of additional value 

that 

The RoHS Directive yields benefits for the 
protection  of  the  environment,  health  and 
for  the  internal  market.  While  it  is  not 
unlikely 
of 
environmental and health protection could 
have  been  achieved  at  national  level,  the 
full  added  value  of  the  RoHS  Directive 
becomes  clear  with 
the 
regard 
facilitation of the internal market. 

similar 

levels 

to 

legislation  on 

Harmonising  standards  to  ease  the  free 
exchange  of  goods  across  the  EU  was 
already  cited  as  one  motivation  for 
proposing 
this  subject 
matter in 2002. The evidence collected for 
this  study,  including  the  statements  from 
business  stakeholders,  suggests  that  the 
same  level  of  harmonisation  could  not 
have  been  achieved  in  the  absence  of 
RoHS. 

Stakeholders 
agree 
that  there  is  a  need 
for 
regulating 
hazardous substances 
in EEE at EU level 

A 
of 
majority 
stakeholders  identify 
negative 
consequences  linked 
or 
to 
stopping 
withdrawing 
the 
Directive 

Opinion  of  stakeholders 
the  Directive’s 
on 
additional  value 
(e.g. 
higher level of ambition, 
less 
administrative 
costs) compared to what 
could  reasonably  have 
been 
at 
national level 

achieved 

Evidence/examples 
of 
additional/lower  value 
that  has  resulted  from 
the  Directive  compared 
to 
could 
reasonably  have  been 
achieved 
at  national 
level 

what 

Opinion 
the 
stakeholders  on  whether 

of 

69 

 
 
 
 
 
 
 
 
 
 
Evaluation (sub) question 

Indicators/Descriptors 

Judgement criteria 

Details on answers 

Analysis (cross-
reference) 

Data sources 

the  issues  addressed  by 
the Directive continue to 
require  action  at  EU 
level 

Evidence/examples  that 
the  issues  addressed  by 
the Directive continue to 
require  action  at  EU 
level 

the 

Opinion  of  stakeholders 
likely 
regarding 
consequences 
of 
stopping or withdrawing 
the Directive 

Evidence/examples  that 
stopping or withdrawing 
the  Directive  would 
have 
positive 
/no/negative 
consequences 

70 

 
 
 
 
 
 
9  ANNEX IV. OVERVIEW OF BENEFITS AND COSTS ESTIMATES 

71 

 
Citizens/Consumers  

Businesses 

Administrations 

[Other …] _ specify 

Quantitati
ve  

Comment 

Quantitative  

Comment 

Quantitative 

Comment   Quantit
ative 

Comment 

Cost or Benefit description 

Mark the type of 
cost/benefit, each on a 
separate line: 

Costs: 

Direct compliance costs 
(adjustment costs, 
administrative costs, 
regulatory charges) 

Enforcement costs: (costs 
associated with activities 
linked to the implementation 
of an initiative such as 
monitoring, inspections and 
adjudication/litigation) 

Indirect costs (indirect 
compliance costs or other 
indirect costs such as 
transaction costs) 

Type: 
Choose 
one-off or 
recurrent 

No 
quantificat
ion 
available 

No  costs  are 
expected 
for 
citizens/consum
ers 

9 = 0 FTE 

13 < 3 FTE 

12 > 3 FTE 

15  –  not  to  be 
specified 
/ 
unknown 

(n=49 
operators) 

business, 

per 
p.a. 

72 

Costs  are  related 
to  collecting  and 
reviewing 
data, 
product 
development, 
providing  supply 
chain 
information, 
maintain 
management 
systems  and 
the 
system 

to 
exemption 

IT 

COM: 

the 

In 
COM: 

~ 1.2 FTE 

COM: 

- 

- 

past, 

Costs  for  staff 
managing 
Directive  and 
external  costs 
for consultants 

Member 
States: 

Member States: 

0.3 – 4.75 FTE 

country, 

Per 
p.a. 

Enforcement 
and 
Implementatio
n 

(n=10 MS) 

EUR 10 000  – 
400 000 

country, 

Per 
p.a. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Benefits: 

Direct benefits (such as 
improved wellbeing: changes 
in pollution levels, safety, 
health, employment; market 
efficiency) 

Indirect benefits (such as 
wider economic benefits, 
macroeconomic benefits, 
social impacts, environmental 
impacts) 

No 
quantification 
available 

No 
quantificat
ion 
available 

Decreased 
negative  health 
to 
effects 
consumer. 
A 
quantification is 
not possible due 
to  the  lack  of 
data 

Protection 
of 
the environment 
reducing 
by 
of 
emissions 
hazardous 
substances 

Directive 
levels 
the  playing  field 
and  creates  legal 
certainty 
for 
businesses.  It  can 
spur 
also 
innovation 
through 
substitutions 

Waste 
management 
market 

Reduction  in  the 
hazardous 
substances 
exposure 
for 
workers 
in 
and 
production 
WEEE  recycling 
plants 

- 

- 

No 
quantifi
cation 
availabl
e 

Creation  of 
similar 
legislation 
outside 
the EU 

of 

circular 

Contributes 
to 
economy, 
improving 
recyclability 
of  EEE,  thus 
reducing 
resource 
consumption 
and  reducing 
CO2 
emissions 

73 

 
 
 
 
 
 
 
 
 
 
 
 
Information on costs extracted from stakeholder consultations 

Direct costs 

In the OPC and targeted consultations and interviews, businesses indicated that it is easier 
to estimate the number of FTEs needed to comply with the RoHS Directive than the direct 
yearly  operational  cost  and  initial  investment  cost.  Some  95  businesses  and  business 
associations provided an answer on the number of FTEs involved. Their response can be 
broken  down  as  follows:  22  responded  ‘none’;  36  responded  ‘other’;  37  provided  FTE 
estimates and 12 of those were business associations. Table 1 below shows the breakdown 
by type of economic actor and by businesses and business association. 

Table 1: Breakdown of companies who submitted FTE estimates (n = 95) 

Number of businesses   Number  of  business 

Raw material supplier 
Distributor /importer 
Manufacturer of components 
Manufacturer 
components 
Other 
Unknown 
Total 

of 

finished 

associations 
6 
0 

5 
24 

6 
10 
49 

1 
3 
5 
22 

11 
2 
46 

More precisely, Table 1 shows: 

•  13 respondents indicated a range of 1-3 FTEs working on RoHS compliance and 12 

respondents indicated a range of more than 3 FTEs. 

•  9 of the respondents indicated that a range of more than 3 FTEs are manufacturers 

of components or finished EEE. 

•  9  respondents  indicated  that  they  do  not  have  FTEs  working  on  compliance  with 

RoHS. 

•  13  respondents  indicated  ‘other’.  Those  respondents  either  indicated  that  it  was 
hard to estimate the number of FTEs or that the number of FTEs was significantly 
higher  than  3.  These  respondents  were  primarily  among  respondents  on  behalf  of 
business dealing with EEE falling under RoHS categories 3, 8, 9, and 11. 

Figures  1  and  2  below,  based  on  data  collected  as  part  of  the  OPC,  show  the  number  of 
FTEs working on compliance to RoHS, by type of company and by organisational size. 

Figure 1: Number of FTEs working on compliance  with RoHS, by type of company 
(n=49) 

74 

 
 
 
 
Less than 1 FTE

Less than 2 FTEs

Less than 3 FTEs

More than 3 FTEs None

8

6

4

2

0

s
e
s
s
e
n
i
s
u
b
f
o
r
e
b
m
u
n

Raw material
supplier

Manufacturer of
components

Manufacturer of
finished
equipment

Distributor/
Importer

Source: OPC 

Figure 2: Number of FTEs working on compliance with RoHS, by organisational 
size (n=49) 

Less than 1 FTE

Less than 2 FTEs

Less than 3 FTEs

More than 3 FTEs Other

Unknown

None

10
8
6
4
2
0

s
e
s
s
e
n
i
s
u
b
f
o
r
e
b
m
u
n

Micro (1 to 9
employees)

Small (10 to 49
employees)

Medium (50 to
249 employees)

Large (250 or
more)

Source: OPC 

Implementation and enforcement 

Table  2:  Cost  estimates  for  enforcement  and  implementation  by  Member  State 
authorities (n=10) 

Enforcement 

FTE 
0.15 - 2.75 

Implementation 
Enforcement 
implementation 
roles are combined) 

and 
(if 

0.15 - 2 
0.3 - 2 

Budget 
EUR 10 000 - EUR 30 000 excluding personnel costs 
EUR 15 000 - EUR 40 000 including personnel costs 
EUR 72 000  -  EUR 125 000  including  personnel  costs  and 
market surveillance 
EUR 100 000 - EUR 125 000 including personnel costs 
EUR 100 000 – EUR 400 000 including personnel costs 
EUR 43 100  (including  all  environmental  research  and 
analysis,  not  just  RoHS  Directive  implementation,  which 
might  be  5%  of  the  total  budget)  -  excluding  costs  for 
personnel 
EUR 10 000 including personnel costs 

Source: Member State survey and other estimates received from Member States 

75 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
10  ANNEX V. STAKEHOLDER CONSULTATION – SYNOPSIS REPORT 

1. 

Introduction 

The  Commission  collected  opinions  of  citizens,  stakeholders,  competent  authorities,  and 
third countries. A wide range of consultation activities was employed to reach out to this 
diverse  group.  This  report  provides  an  overview  of  the  consultation  strategy  and  the 
individual  activities.  In  addition,  it  reports  on  the  number  of  people  and  organisations 
engaged and provides some of the main outcomes. 

2.  The consultation strategy 

The  consultation  strategy  was  published  jointly  with  the  publication  of  the  RoHS 
Directive’s  evaluation  roadmap132.  To  further  elaborate  the  consultation  strategy,  the 
research  team  mapped  the  stakeholders,  identifying  all  relevant  groups  and  suitable 
consultation  tools  to  reach  out  to  them.  The  aims  of  the  consultation  were  to  collect 
information,  data,  evidence  and  opinions  and  to  complement  the  desk  research.  The 
stakeholder consultation activities consisted of: 

-  a  feedback  period  on  the  RoHS  Directive’s  evaluation  roadmap,  which  ran  from 

14 September 2018 to 12 October 2018; 

-  an OPC, which ran from 13 September 2019 to 6 December 2019; 

-  an  in-depth  survey  (questionnaire)  shared  with  Member  State  authorities  involved  in 

implementing the RoHS Directive, in parallel to the OPC; 

- 

- 

three focus groups, organised between October 2019 and March 2020; 

in-depth  interviews,  organised  partly  as  follow-up  interviews  to  input  stakeholders 
provided via the OPC; 

-  a workshop organised towards the end of the study in March 2020 to present the study’s 
preliminary findings and provide stakeholders with another opportunity to provide their 
input. 

Many stakeholders shared their experiences with implementing the Directive and provided 
additional  supporting  evidence.  Information  was  collected  on  all  five  evaluation  criteria 
covered  by  the  evaluation:  effectiveness,  efficiency,  relevance,  coherence  and  EU  added 
value. 

The  following  sections  provide  information  on  all  consultation  activities.  Each  section 
provides  an  overview  of  the  nature  and  number  of  respondents.  The  sections  also 
summarise the main outcomes of each of the consultation activities. 

3.  Online public consultation 

3.1  Participants 

The  OPC  remained  open  for  12  weeks,  in  line  with  the  requirements  of  the  Better 
Regulation  guidelines.  The  questionnaire  for  the  OPC  was  uploaded  to  the  EU  Survey 

132 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1891-Restriction-of-hazardous-

substances-evaluation 

76 

 
 
website  and  translated  by  the  translation  service  of  the  European  Commission  into  24 
languages. 

The  OPC  was  open  to  anyone  interested.  The  questionnaire  was  structured  into  three 
sections.  The  introductory  section  collected  some  background  information  on  the 
respondents.  The  second  section  contained  questions  tailored  to  respondents  who  self-
identified  as  non-experts,  while  the  third  section  targeted  experts,  i.e.  stakeholders  with 
specific  knowledge  on  hazardous  substances  in  EEE.  The  questions  in  each  section 
reflected the level of expected knowledge of the respondents and were thus more detailed 
for experts than for non-experts. Every respondent filled in two out of the three sections of 
the questionnaire, with the introductory section being filled in by everyone. Depending on 
their  profile  (non-expert  or  expert),  respondents  also  filled  in  either  the  second  or  third 
section of the questionnaire. In total, 163 responses were collected, of which 125 responses 
(77%) were directly submitted via the EU Survey website. In addition, a representative of 
the  UK’s  Enterprise  Europe  Network  submitted  additional  38  responses  (23%)  to  the 
general part of the survey from companies via an uploaded file as part of an answer to the 
OPC. One completely empty response was removed from the sample. 

The majority of replies came from respondents in the UK (51 responses) and Belgium (32 
responses), followed by Germany (25) and Japan (16 responses) (Table 1). Almost half of 
the replies, 77 responses, were from respondents outside the EU (Japan, United Kingdom, 
Switzerland, others)133. 

Table 4 Overview of country of origin of respondents to the OPC 

Country  Responses  % 

Belgium 

32 

Denmark  1 

Finland 

France 

2 

6 

Germany  25 

Ireland 

Israel 

Italy 

2 

1 

7 

20% 

1% 

1% 

4% 

15% 

1% 

1% 

4% 

Japan 

16 

10% 

  Country 
Lithuania 

1 

Responses  % 

Netherlands  2 

Portugal 

Spain 

Sweden 

2 

2 

4 

Switzerland  1 

1% 

1% 

1% 

1% 

2% 

1% 

United 
Kingdom 

United 
States 

Total 

13 (+38) 

8 

163 

31% 

5% 

100% 

Note: as mentioned above, we considered 162 responses for the analysis. 

About  four  out  of  five  respondents  indicated  that  they  have  specific  knowledge  in  the 
policy  field  and/or  on  the  RoHS  Directive.  Therefore,  a  clear  majority  (63%)  of 
respondents filled in the longer and more detailed version of the public consultation, while 
61  respondents  (37%)  filled  in  the  shorter  and  more  general  version.  Companies  and 
business  associations  submitted more than 70%  of all responses (see  Table 2 below). As 

133 At the time the OPC was open, the UK was still a Member State. 

77 

 
 
 
 
 
 
 
 
 
 
 
mentioned above, a significant  share of these (16 replies) was from  Japanese companies; 
this could be an indication of the importance of the RoHS Directive for international trade. 

Table 5 Distribution of responses by stakeholder group 

Stakeholder type 

Responses 

Business association/ Company 

Academic/research institution 

EU citizen 

Non-EU citizen 

NGO 

Other 

Public authority 

128 

1 

22 

2 

2 

3 

5 

% 

79% 

1% 

13% 

1% 

1% 

2% 

3% 

Because  of  the  sample  size,  self-selection  and  unequal  geographical  distribution,  the 
responses to these questions should not be considered representative of a wider sample or 
of citizens of the EU overall. 

3.2  Outcome of the questionnaire for the non-experts 

Questions for non-experts mostly focused on respondents’ perceptions. They explored the 
perceived  safety  of  products  for  consumers,  and  explored  whether  respondents  were 
willing  to  accept  potential  trade-offs  between the safety  of EEE for the environment  and 
health  on  the  one  side,  and  the  cost  of  EEE  on  the  other  side.  The  questions  further 
explored the recycling habits of respondents  as  well as the perceived added value of EU 
interventions in this policy field. 

Figure  1 Number of responses by category: Has the legislation helped to reduce the 
use of hazardous substances in electrical and electronic equipment? 

50%

45%

40%

35%

30%

25%

20%

15%

10%

5%

0%

Yes

No

Don't know/
blank

Yes

No

Don't know/
blank

Citizens

Businesses

For  this  section  of  the  questionnaire,  which  targets  non-experts,  out  of  the  62  replies 
collected, one business association provided one completely empty response. As such, the 
research team considered 61 replies for this sample instead of 62. 42 responses (69%) were 
from  businesses,  18  (30%)  from  individuals  and  1(1%)  from  an  NGO  (considered  in  the 

78 

 
 
category ‘citizens’ in Figure 2). The majority of the respondents recognised that the RoHS 
Directive helped to protect human health and to reduce damage to the environment, either 
fully  or  to  a  limited  extent.  Although  42%  of  respondents  agreed  that  the  legislation  has 
helped to reduce the use of hazardous substances in EEE, 69% of the businesses indicated 
that this impact of the legislation was unknown. 

Most  of  the  businesses  (93%,  in  total  39)  and  citizens  (95%,  in  total  18)  agreed  on  the 
necessity of restrictions on hazardous substances in EEE to protect the environment. 

3.3  Outcome of the questionnaire for experts 

A total of 101 respondents filled in the part of the OPC questionnaire for experts and not 
the  non-experts’  questions.  Businesses  and  their  associations  submitted  86  responses 
(85%), with the remaining 15 (15%) coming from academia, NGOs, public authorities and 
individual  experts.  Therefore,  the  results  of  this  part  of  the  public  consultation  are  very 
much driven by perceptions of industry representatives. 

Similar  to  the  respondents  to  the  general  part  of  the  public  consultation,  a  substantial 
majority of respondents to the specific parts agreed that the Directive has helped reduce the 
use of hazardous substances in EEE and thus helped protect the environment. 

Information from respondents suggests that implementing the RoHS Directive has resulted 
in  additional  costs  for  businesses.  A  majority  of  respondents  indicated  that  they  had 
incurred one-off costs and increased operational costs due to implementing the Directive. 

Figure 2 Number of responses by category: Have you made any initial investment to 

comply with RoHS? 

60%

50%

40%

30%

20%

10%

0%

Yes

No

Don't know/
blank

Yes

No

Don't know/
blank

Businesses & Associations

Others

Figure  3:  Number  of  responses  by  category:  Has  your  operational  costs  /  the 
operational costs for the companies you represent increased due to compliance with 
RoHS? 

80%
70%
60%
50%
40%
30%
20%
10%
0%

Yes

No

Don't know/
blank

Yes

No

Don't know/
blank

Businesses & Associations

Others

79 

 
 
 
A majority of stakeholders stated that legislation such as the RoHS Directive is still needed 
to protect the environment, with 75% of respondents to the expert questionnaire agreeing 
with  this  statement.  More  than  one  in  two  respondents  also  indicated  that  the  Directive 
simplifies trade within the EU. In line with this, three out of four respondents would expect 
negative consequences if the RoHS Directive were to be withdrawn. 

Figure 4 Number of responses by category: There is still a need for EU legislation on 
hazardous  substances 
in  electrical  and  electronic  equipment  to  protect  the 
environment? 

35%
30%
25%
20%
15%
10%
5%
0%

Strongly
agree

Agree Disagree Strongly
disagree

Don't
know/
blank

Strongly
agree

Agree Disagree Strongly
disagree

Don't
know/
blank

Businesses & Associations

Others

3.4  Additional input and position papers 

In  addition  to  a  set  of  closed  questions,  respondents  were  invited  to  provide  additional 
details  and  information  in  open  questions.  The  two  questionnaires  allowed  space  for 
respondents to share any additional information as desired and provided the opportunity to 
upload a position paper. 

In total, 40 (25%) respondents (out of 163 respondents) provided additional information134. 
17 (10%) respondents pointed out several overlaps between the RoHS Directive and other 
EU  legislation  such  as  the  Ecodesign  Directive,  the  REACH  Regulation,  the  Energy-
related  Products  (ErP)  Directive,  the  Waste  Framework  Directive  and  the  Persistent 
Organic Pollutants (POPs) Regulation. In their responses, several participants to the public 
consultation focused on the exemption system. For example, they considered the duration 
of the exemption process to be too lengthy and asked for longer exemption periods in cases 
where  research  is  exhaustive  and  no  substitutes available.  Two  stakeholders  also  pointed 
out  the  needs  and  limitations  of  specific  sectors,  including  medical  equipment  and 
entertainment lighting. 

4.  Questionnaire to Member States 

4.1 Participants 

A targeted questionnaire was developed for Member State competent authorities in charge 
of implementing the RoHS Directive. Special attention was paid to information likely to be 
held  exclusively  or predominantly by Member State authorities.  In addition,  the Member 
States were also asked about the state of implementation of the Directive in their respective 
jurisdictions. The questionnaire was launched in the second half of September 2019 and a 

134 This includes a number of comments concerning the questionnaire, as well as responses such as  ‘None’, 

and responses pointing to position papers. 

80 

 
 
 
reminder  was  sent  by  the  Commission  to  respondents  at  the  end  of  October  2019.  A 
reminder was also  sent  to  respondents  who had entered their email  contact  in  the system 
but not yet responded. 

A  total  of  20  responses  were  received.  13  (65%)  respondents  fully  completed  the 
questionnaire, whereas six (30%) responded partially. Responses cover 15 Member States 
as well as Norway. 

Figure 5 Overview of Member States that responded to the questionnaire 

4.2 Outcome 

Member  State  representatives  responding  to  the  targeted  survey  overall  assessed  the 
Directive  positively  in  terms  of  achieving  its  objectives.  A  clear  majority  of  respondents 
stated that the safety of EEE for humans and the environment had improved in the last 10 
years, and that RoHS led to reduced use of harmful substances in EEE. 

Figure 6 Responses to the question: Has the RoHS Directive helped to reduce the use 
of hazardous substances in electrical and electronic equipment in the EU? 

s
e
s
n
o
p
s
e
r

f
o
r
e
b
m
u
N

100%

80%

60%

40%

20%

0%

Yes

No

I don't know

No asnwer

Member  State  representatives  responding  to  the  survey  indicated  that  withdrawing  the 
RoHS  Directive  would  have  negative  consequences  for  achieving  the  Directive’s  four 

81 

 
 
 
 
 
 
objectives.  Eleven  respondents  believed  that  withdrawing  the  Directive  would  have 
negative  consequences  for  the  protection  of  human  health  and  for  the  environmentally 
sound  recovery  and  disposal  of  WEEE.  Thirteen  Member  States  believed  a  withdrawal 
would  have  negative  consequences  for  the  protection  of  the  environment,  and  9 
respondents  expected  that  it  would  have  negative  consequences  in  terms  of  ensuring  a 
well-functioning internal market. 

Figure 7 Responses to the question: What consequences do you think the withdrawal 
of  the  RoHS  Directive  would  have  for  achieving  the  objectives  of  the  Directive?  - 
Ensuring a well-functioning internal market 

s
e
s
n
o
p
s
e
r

f
o
r
e
b
m
u
N

100%

80%

60%

40%

20%

0%

Positive
consequences

Negative
consequences

Don't know

No answer

All  Member  State  representatives  agreed  (5  respondents,  25%)  or  strongly  agreed  (10 
respondents, 50%) that the restriction of hazardous substances in EEE continued to require 
action at EU level. 

5. 

Focus groups 

1 Participants 

Three focus  groups were organised in  the context of this study, with  a view  to  gathering 
views  from  representatives  of  Member  State  competent  authorities,  the  business 
association,  and  NGOs.  The  participants  in  the  focus  group  expressed  interest  in  the 
activity and were therefore invited. The topics covered were: 

•  assessment of the Directive’s implementation and enforcement 
•  effectiveness and efficiency – environmental and health aspects 
•  effectiveness and efficiency– costs and benefits aspects 
•  external and internal coherence 

2 Outcome 

Assessment of the Directive’s implementation and enforcement 

The  first  focus  group  with  relevant  Member  States  authorities  from  8  countries  (10 
participants)  was  held  on  22 October  2019  in  Brussels.  The  emphasis  of  the  first  focus 
group was on the implementation and enforcement processes currently in place across the 
countries,  as  well  as  on  the  Directive’s  effectiveness  and  efficiency.  Furthermore,  the 
baseline  methodology  developed  by  the  project  team  to  assess  the  likely  impact  of  the 
Directive was presented and discussed. Member State competent authorities attending the 
focus group considered that there was a lack of clarity regarding market surveillance and 
asked for further guidance from the Commission. 

82 

 
 
 
 
 
 
Effectiveness and efficiency – environmental and health aspects 

The second focus group with NGOs took place on 12 December 2019. Three organisations 
attended,  bringing  together  3  participants  and  3  members  of  the  research  team.  The 
participants  discussed whether the RoHS  Directive is  effective  and  efficient  in  achieving 
its environmental- and health-related objectives. Overall, they agreed that the Directive is 
delivering on its objectives, although they still see room to improve. They discussed how 
the  RoHS  is  implemented  and  if  there  are  aspects  that  hinder  its  effectiveness  and 
efficiency. For example, they noted that granting too many exemptions can undermine the 
Directive’s effectiveness. 

Stakeholders from the NGO focus group stated that one of the Directive’s main benefits is 
that many companies changed and started understanding the need for efficient management 
of chemicals. 

Effectiveness and efficiency – costs and benefits aspects / External and internal coherence 

The third focus group, this time involving 10 representatives of business associations, was 
organised  on  4 March  2020.  In  addition  to  gathering  information  and  evidence  on  the 
effectiveness,  efficiency  and coherence of the RoHS  Directive from  the point of view of 
business  associations,  the  focus  group  intended  to  collect  examples  for  the  Directive’s 
potential  impacts  and  effects  on  business  operators.  More  specifically,  the  focus  group 
explored  various  effects  of  the  Directive,  e.g.  its  benefits,  impact  on  innovation  and  the 
circular  economy,  the  impact  and  shortcomings  of  the  exemption  system,  as  well  as  the 
costs incurred by businesses to comply with the Directive. 

The first part of the meeting focused on effectiveness and, more especially, on the impact 
of the RoHS Directive on innovation, competitiveness and internal market. The group also 
considered  the  potential  situation  without  the  RoHS  Directive.  On  this  latter  issue,  the 
stakeholder  agreed  that  leaving  the  matter  of  the  RoHS  Directive  to  the  Member  States 
would  not  have  been  better.  The  second  part  of  the  focus  group  focused  on  efficiency  - 
more specifically, the RoHS Directive’s costs and benefits. This provided the opportunity 
to  validate  and  discuss  the  estimated  investments  costs  identified  by  the  team.  The  third 
and  last  part  of  the  meeting  focused  on  the  Directive’s  internal  and  external  coherence. 
During  the  last  session,  stakeholders’  inputs  indicated  that  there  are  several  overlaps 
between the RoHS Directive and other EU legislation. 

6.  Targeted interviews 

1 Participants 

The  interviews  were  conducted  between  July  2019  and  February  2020  with  relevant 
stakeholders from EU Member States and from other relevant countries, including Japan. 
Scoping interviews were performed at an early stage and then more structured interviews 
were used to complement information from desk research and other consultation activities. 

Overall,  15  interviews  were  performed:  11  with  businesses,  3  with  authorities  from 
Member States and 1 with a consultancy / research institute. The research team tailored the 
interview questionnaires for each interviewee, thus making it possible to focus on the most 
relevant topics for each interview. Common points of discussions included the Directive’s 
cost and benefits, its impact on innovation, and its consistency with other EU legislation. 
The research team interviewed experts that: 

- 

contacted the research team; 

-  were suggested by DG ENV; 

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- 

replied to the OPC and for which a follow-up interview was deemed useful. 

The interviews with Member State authorities were also used as an opportunity to follow 
up on information already provided via the specific questionnaire. In one case, the agency 
interviewed was different from the one that responded to the questionnaire. 

2 Outcome 

All  the  interviewees  agreed  that  the  RoHS  Directive  should  stay  in  place  and  that  the 
situation  would  not  have  been  better  without  it.  The  Directive  allows  for  effective 
enforcement  on  a  level  playing  field,  mainly  due  to  the  CE  marking.  However,  across 
Europe there are different enforcement cultures and thus scenarios. 

Overall, the interviewees agreed that the compliance cost increased from RoHS 1 to RoHS 
2.  This  was  because  the  latter  directive  came  with  requirements  for  CE  labelling  and 
further technical documentation. 

As in the OPC, the interviewees pointed out the overlaps and coherence issues with other 
EU legislation, especially REACH, the POPs Regulation, and the Ecodesign Directive. The 
interviewees  agreed  on  the  international  dimension  of  RoHS  and  the  opportunities  and 
challenges  arising  from  the  fact  that  a  growing  number  of  countries  are  implementing 
RoHS-like  legislation.  For  instance,  it  is  difficult  for  non-EU  states  to  understand  the 
RoHS Directive; hence, there is not full harmonisation across the globe. 

The interviews with Member State competent authorities focused on issues related to the 
Directive’s implementation and enforcement (e.g. inspections and controls, sanctions, etc.), 
exploring how the Directive has affected the authorities. The authorities cited problems in 
enforcement activities regarding exemptions, and stressed that technical documentation is 
complex and hard to follow for someone who is not a technician, which causes difficulties 
in enforcement. 

Furthermore, the business associations stressed several issues with the exemption system; 
e.g.  it  is  too  lengthy  and  generates  significant  administrative  burdens.  Also,  R&D  is 
somehow  limited  under  the  Directive,  as  money  is  spent  on  compliance  and  exemption 
processes. 

7.  Workshop 

The  workshop  was  held  in  March  2020.  Due  to  the  ongoing  COVID-19  crisis,  it  was 
organised as an online webinar. The research team invited all the organisations that: 

- 

contacted the research team during the study; 

-  were recommended by the European Commission for consultation; 

-  participated in the consultation activities; 

-  were identified during the mapping of stakeholders. 

Around  125  individuals  (including  the  research  team  and  the  European  Commission) 
joined  the  webinar.  It  brought  together  representatives  from  12  Member  States  (among 
which 3 national institutions replied to the questionnaire), the European Commission, and 
53 representatives from NGOs and industry. The organisations interviewed, and those that 
took part in the focus groups also participated in the workshop. Ahead of the workshop 25 
organisations sent a contribution. 

The workshop covered the five criteria set out in the EU Better Regulation guidelines, i.e. 
effectiveness,  efficiency,  coherence,  relevance  and  EU  added  value.  It  provided  the 

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participants with the opportunity to comment on the study’s preliminary findings for each 
criterion, which they received prior to the webinar. The stakeholders devoted considerable 
attention  to  the  Directive’s  impact  on  innovation,  the  costs  and  administrative  burden 
related  to  the  different  categories  of  EEE  covered  under  RoHS  and  the  Directive’s 
consistency with the circular economy initiative. 

Overall,  participants  agreed  with  the  study’s  preliminary  findings.  However,  it  was 
highlighted  that  further  qualitative  and  quantitative  data  from  the  stakeholders  could  be 
used,  and  that  the  definition  of  innovation  could  contribute  to  assessing  the  Directive’s 
impact on this matter more precisely. 

The  workshop  also  represented  a  last  call  for  data  and  evidence;  participants  were  given 
the  possibility  to  provide  final  feedback  (in  written  form)  both  during  and  after  the 
workshop – 15 organisations sent a contribution. 

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